Trial Outcomes & Findings for Retrospective Study on Referral Patterns for High Risk Patients Post Nephrectomy (NCT NCT04309617)
NCT ID: NCT04309617
Last Updated: 2021-05-19
Results Overview
Follow- up time (in years) was duration between index date to the last entry in the medical record, death, or disease recurrence. The date of nephrectomy was considered as index date.
COMPLETED
618 participants
From index date to the last entry in the medical record, death, or disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
2021-05-19
Participant Flow
Medical record data, for participants with locoregional renal cell carcinoma (RCC), who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019, were compiled retrospectively by Duke researchers via an institutional database.
Data collected were observed and evaluated in this study's duration of approximately 9 months.
Participant milestones
| Measure |
All Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Overall Study
STARTED
|
618
|
|
Overall Study
Modified High Risk of Recurrence
|
136
|
|
Overall Study
COMPLETED
|
618
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In this baseline measure, duration (in days) from time of RCC diagnosis to nephrectomy was reported. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
Baseline characteristics by cohort
| Measure |
All Participants
n=618 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Age, Continuous
|
61.67 years
STANDARD_DEVIATION 11.15 • n=618 Participants
|
|
Sex/Gender, Customized
Male
|
417 Participants
n=618 Participants
|
|
Sex/Gender, Customized
Female
|
200 Participants
n=618 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=618 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=618 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=618 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
460 Participants
n=618 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
57 Participants
n=618 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
103 Participants
n=618 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
458 Participants
n=618 Participants
|
|
Time from RCC Diagnosis to Nephrectomy
|
5.03 days
STANDARD_DEVIATION 69.50 • n=616 Participants • In this baseline measure, duration (in days) from time of RCC diagnosis to nephrectomy was reported. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage
Stage 1
|
420 Participants
n=618 Participants
|
|
Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage
Stage 2
|
65 Participants
n=618 Participants
|
|
Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage
Stage 3
|
133 Participants
n=618 Participants
|
|
Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage
Stage 4
|
0 Participants
n=618 Participants
|
|
Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade
Grade 1
|
71 Participants
n=595 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade
Grade 2
|
401 Participants
n=595 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade
Grade 3
|
95 Participants
n=595 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade
Grade 4
|
28 Participants
n=595 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Number of Participants Classified According to Clear Cell Predominance
Yes
|
457 Participants
n=618 Participants
|
|
Number of Participants Classified According to Clear Cell Predominance
No
|
161 Participants
n=618 Participants
|
|
Mean Tumor Size
|
5.27 centimeter
STANDARD_DEVIATION 3.39 • n=616 Participants • In this baseline measure, mean tumor size of participants was reported. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Number of Participants Classified According to Tumor Necrosis
Present
|
156 Participants
n=614 Participants • In this baseline measure, participants were classified per presence or absence of tumor necrosis. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Number of Participants Classified According to Tumor Necrosis
Absent
|
458 Participants
n=614 Participants • In this baseline measure, participants were classified per presence or absence of tumor necrosis. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Number of Participants Classified According to Nephrectomy Year
2014
|
0 Participants
n=618 Participants
|
|
Number of Participants Classified According to Nephrectomy Year
2015
|
80 Participants
n=618 Participants
|
|
Number of Participants Classified According to Nephrectomy Year
2016
|
131 Participants
n=618 Participants
|
|
Number of Participants Classified According to Nephrectomy Year
2017
|
120 Participants
n=618 Participants
|
|
Number of Participants Classified According to Nephrectomy Year
2018
|
128 Participants
n=618 Participants
|
|
Number of Participants Classified According to Nephrectomy Year
2019
|
159 Participants
n=618 Participants
|
|
Number of Participants Classified According to Type of Nephrectomy
Full
|
295 Participants
n=618 Participants
|
|
Number of Participants Classified According to Type of Nephrectomy
Partial
|
323 Participants
n=618 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
132 Participants
n=269 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
129 Participants
n=269 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
8 Participants
n=269 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
0 Participants
n=269 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4
|
0 Participants
n=269 Participants • Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this baseline measure.
|
PRIMARY outcome
Timeframe: From index date to the last entry in the medical record, death, or disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included all eligible participants whose data were retrieved from medical records and studied.
Follow- up time (in years) was duration between index date to the last entry in the medical record, death, or disease recurrence. The date of nephrectomy was considered as index date.
Outcome measures
| Measure |
All Participants
n=618 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Follow-up Duration
|
1.07 years
Interval 0.0 to 4.87
|
PRIMARY outcome
Timeframe: At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included all eligible participants whose data were retrieved from medical records and studied. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
In this outcome measure number of participants were classified according to their follow-up plan determined at first post-operative visit. Follow-up plans were as follows: 1) surveillance, 2) adjuvant systemic therapy (AST), 3) follow-up plan not recorded in the medical record and 4) other.
Outcome measures
| Measure |
All Participants
n=552 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit
Surveillance
|
519 Participants
|
|
Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit
AST
|
25 Participants
|
|
Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit
Not Recorded
|
5 Participants
|
|
Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit
Other
|
3 Participants
|
PRIMARY outcome
Timeframe: At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included all eligible participants whose data were retrieved from medical records and studied. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
In this outcome measure number of participants with transfer of care to a non-Duke provider were reported.
Outcome measures
| Measure |
All Participants
n=536 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants With Transfer of Care to a Non-Duke Provider
|
36 Participants
|
PRIMARY outcome
Timeframe: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here 'Overall Number of Participants Analyzed' signifies participants who were followed up for evaluation for any referral.
Among number of participants who were followed up for any referral, those participants who had no documented oncologic/RCC related care referrals were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=119 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
|
88 Participants
|
PRIMARY outcome
Timeframe: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were referred for oncologic/RCC-related care.
Number of participants according to the type of provider who referred for oncologic or RCC related care after nephrectomy were recorded and reported. Type of providers included urologist, primary care, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=31 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Urologist
|
31 Participants
|
|
Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Primary Care
|
0 Participants
|
|
Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Other
|
0 Participants
|
PRIMARY outcome
Timeframe: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were referred for oncologic/RCC-related care.
Number of participants according to the type of provider referred to, for oncologic/RCC related care after nephrectomy were recorded and reported. Type of providers to whom participants were referred included medical oncologist, radiation oncologist, urologist, interventional radiologist, and medical geneticist. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=31 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Medical Oncologist
|
29 Participants
|
|
Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Radiation Oncologist
|
0 Participants
|
|
Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Urologist
|
0 Participants
|
|
Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Interventional Radiology
|
1 Participants
|
|
Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Medical Geneticist
|
1 Participants
|
PRIMARY outcome
Timeframe: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were referred for oncologic/RCC-related care.
Number of participants according to reasons for being referred to oncologic or RCC related care after nephrectomy were recorded and reported. Reasons included discussion of adjuvant systemic therapy (AST) options, other discussion of management options, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=31 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Discussion of AST Options
|
25 Participants
|
|
Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Other Discussion Management Options
|
2 Participants
|
|
Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Other
|
4 Participants
|
PRIMARY outcome
Timeframe: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were referred for oncologic/RCC-related care and were evaluable for this outcome measure.
After nephrectomy, time (in days) to any referral for oncologic or RCC related care was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=27 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group
|
50.00 days
Interval 16.0 to 812.0
|
PRIMARY outcome
Timeframe: From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who had any subsequent surgery after nephrectomy.
Time from nephrectomy (in months) up to the subsequent surgery was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=5 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group
|
11.90 months
Interval 3.21 to 22.02
|
PRIMARY outcome
Timeframe: From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who had any subsequent surgery after nephrectomy.
Number of participants according to the type of subsequent surgery after nephrectomy were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=5 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group
Radical Nephrectomy
|
1 Participants
|
|
Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group
Partial Nephrectomy
|
0 Participants
|
|
Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group
Other
|
4 Participants
|
PRIMARY outcome
Timeframe: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy.
Time from nephrectomy up to the first-line AST was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=3 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group
|
82.00 days
Interval 76.0 to 117.0
|
PRIMARY outcome
Timeframe: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy.
Number of participants according to type of systemic agents received as first-line AST were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=3 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group
Sunitinib
|
1 Participants
|
|
Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group
Clinical Trial - Agent Not Specified
|
2 Participants
|
PRIMARY outcome
Timeframe: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy and were evaluable for this outcome measure.
Mean of starting dose of first-line AST received after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=2 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group
|
125.00 milligram
Standard Deviation 106.07
|
PRIMARY outcome
Timeframe: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy.
In this outcome measure number of participants who were treated with first-line AST after nephrectomy as a part of clinical trial in adjuvant setting were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=3 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Who Were Treated With First-line AST as Part of a Clinical Trial in the Adjuvant Setting: Modified High Risk Sub-group
|
2 Participants
|
PRIMARY outcome
Timeframe: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who received first-line AST after nephrectomy and were evaluable for this outcome measure.
In this outcome measure number of participants were classified according to reason for discontinuation of treatment with first-line AST after nephrectomy. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=2 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group
Adverse Event
|
1 Participants
|
|
Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group
Disease Progression
|
1 Participants
|
PRIMARY outcome
Timeframe: From nephrectomy up to the follow-up, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who were followed up related to RCC after nephrectomy.
RCC related follow-up duration after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=107 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group
|
1.57 years
Interval 0.04 to 4.85
|
PRIMARY outcome
Timeframe: From nephrectomy up to death by any cause, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=118 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Who Died: Modified High Risk Sub-group
|
15 Participants
|
PRIMARY outcome
Timeframe: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who had RCC recurrence after nephrectomy.
Number of participants according to the type of disease recurrence are reported. Type of disease recurrence were locoregional and distant. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=42 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group
Locoregional
|
4 Participants
|
|
Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group
Distant
|
38 Participants
|
PRIMARY outcome
Timeframe: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence. Here "Overall Number of Participants Analyzed" signifies participants who had RCC recurrence after nephrectomy and were evaluable for this outcome measure.
Time from nephrectomy to recurrence (in months) was defined as the time from nephrectomy to the high risk of RCC recurrence or end of participant record or receipt of systemic therapy or death due to any cause. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=40 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Time From Nephrectomy to Recurrence: Modified High Risk Sub-group
|
5.72 months
Interval 1.02 to 46.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From nephrectomy up to earliest documentation of high-risk of recurrence or death, approximately during 5 years (data observed during 9 months of retrospective study)Population: Analysis population included participants who were at modified high risk of recurrence.
DFS was defined as the time interval (in months) from date of nephrectomy to earliest documentation of high-risk of RCC recurrence or death. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Outcome measures
| Measure |
All Participants
n=136 Participants
Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study.
|
|---|---|
|
Disease Free Survival (DFS): Modified High Risk Sub-group
|
NA months
Interval 40.6 to
Median and upper limit of CI was not estimable due to low number of participants who had event.
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER