Trial Outcomes & Findings for Feasibility Clinical Study of Targeted and Genome-Wide Sequencing (NCT NCT01345513)
NCT ID: NCT01345513
Last Updated: 2020-03-23
Results Overview
Average and range of time (in calendar days) that occurred between study participants providing informed consent to the reporting of genomic results to the physician.
COMPLETED
50 participants
All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.
2020-03-23
Participant Flow
Participant milestones
| Measure |
Solid Tumor Cancer
Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Solid Tumor Cancer
n=50 Participants
Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
|---|---|
|
Age, Continuous
|
57 years
n=50 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=50 Participants
|
|
Time Since Metastatic Diagnosis (Months)
|
17.2 months
n=50 Participants
|
|
Number of Prior Treatment Regimens
|
3 prior treatment regimens
n=50 Participants
|
|
Primary Tumour Type
Colorectal
|
9 Participants
n=50 Participants
|
|
Primary Tumour Type
Breast
|
8 Participants
n=50 Participants
|
|
Primary Tumour Type
Ovarian
|
8 Participants
n=50 Participants
|
|
Primary Tumour Type
NSCLC
|
5 Participants
n=50 Participants
|
|
Primary Tumour Type
Prostate
|
3 Participants
n=50 Participants
|
|
Primary Tumour Type
Anal
|
2 Participants
n=50 Participants
|
|
Primary Tumour Type
Mesothelioma
|
2 Participants
n=50 Participants
|
|
Primary Tumour Type
Head & Neck
|
2 Participants
n=50 Participants
|
|
Primary Tumour Type
Other
|
11 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.Average and range of time (in calendar days) that occurred between study participants providing informed consent to the reporting of genomic results to the physician.
Outcome measures
| Measure |
Solid Tumor Cancer
n=49 Participants
Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
|---|---|
|
Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients
|
21 calendar days
Interval 7.0 to 63.0
|
SECONDARY outcome
Timeframe: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.Number of participants with actionable genomic results (defined as having the potential to impact on management recommendations based on diagnostic, prognostic and/or predictive implications), expressed as a percentage of the total number of study participants.
Outcome measures
| Measure |
Solid Tumor Cancer
n=49 Participants
Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
|---|---|
|
Number of Participants With Actionable Genomic Results
|
16 Participants
|
SECONDARY outcome
Timeframe: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.Population: Of the 49 patients analyzed, 8 experienced adverse events related to tumour biopsies during the study. Minor events included bruising, bleeding and minor infections. Serious events included pneumothorax and cellulitis.
Number of participants with any adverse events possibly, probably or definitely related to tumor biopsies on study; Grading by CTCAE version 4 of adverse events.
Outcome measures
| Measure |
Solid Tumor Cancer
n=8 Participants
Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
|---|---|
|
Number of Participants With Adverse Events Due to Tumor Biopsies on Study
Minor (as per CTCAE)
|
6 Participants
|
|
Number of Participants With Adverse Events Due to Tumor Biopsies on Study
Serious (as per CTCAE)
|
2 Participants
|
SECONDARY outcome
Timeframe: All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.Population: Data were not collected.
Qualitative and quantitative responses on questionnaires and personal interviews regarding patient and physician experience of this research process and their understanding of genomic analysis including perceptions of benefit versus disadvantages, impact on clinical care and decision making
Outcome measures
Outcome data not reported
Adverse Events
Solid Tumor Cancer
Serious adverse events
| Measure |
Solid Tumor Cancer
n=49 participants at risk
Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Pneumothorax
|
2.0%
1/49 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Grade 3 Cellulitis
|
2.0%
1/49 • Number of events 1
|
Other adverse events
| Measure |
Solid Tumor Cancer
n=49 participants at risk
Sample Collection for Genome-Wide Sequencing: Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Grade 1 Bruising
|
12.2%
6/49 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Grade 1 Bleeding
|
12.2%
6/49 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Grade 2 Wound Infection
|
2.0%
1/49 • Number of events 1
|
Additional Information
Janet E. Dancey
Ontario Institute for Cancer Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place