Trial Outcomes & Findings for Association of Hepatitis C Virus With Breast Cancer (NCT NCT04090164)
NCT ID: NCT04090164
Last Updated: 2020-10-19
Results Overview
Percentage of patients with breast cancer with positive anti-HCV serological test.
COMPLETED
650 participants
This outcome will be assessed through study completion, an average of 6 months.
2020-10-19
Participant Flow
The Hospital medical record system was searched to identify patients with the "malignant neoplasm of the breast" diagnosis. The information of an un-selected sample of 650 patients was retrieved from the system. Two-hundred forty-five patients with incomplete data were excluded. The remaining 405 patients were subjected for further analysis.
The study group was retrospectively extracted from hospital file. However, The "Dakahlia Governorate adult female Population" is a historical control group derived from the raw data of a previous study. As such, this control group has not been recruited in the current study.
Participant milestones
| Measure |
Study Group
The data of breast cancer patients treated at OCMU in the last 10 years will be retrieved from the hospital data filing system. All consecutive patients with biopsy-proven invasive breast cancer will be included.
|
Dakahlia Governorate Adult Female Population
One-hundred forty-five adult females from Dakahlia governorate were sampled in a published population-based cross sectional study from 2015 to 2017.
\[El-Ghitany EM, Farghaly AG (2019) Geospatial epidemiology of hepatitis C infection in Egypt 2017 by governorate. Heliyon 5 (8):e02249. doi:10.1016/j.heliyon.2019.e02249}
|
|---|---|---|
|
Overall Study
STARTED
|
650
|
145
|
|
Overall Study
COMPLETED
|
405
|
145
|
|
Overall Study
NOT COMPLETED
|
245
|
0
|
Reasons for withdrawal
| Measure |
Study Group
The data of breast cancer patients treated at OCMU in the last 10 years will be retrieved from the hospital data filing system. All consecutive patients with biopsy-proven invasive breast cancer will be included.
|
Dakahlia Governorate Adult Female Population
One-hundred forty-five adult females from Dakahlia governorate were sampled in a published population-based cross sectional study from 2015 to 2017.
\[El-Ghitany EM, Farghaly AG (2019) Geospatial epidemiology of hepatitis C infection in Egypt 2017 by governorate. Heliyon 5 (8):e02249. doi:10.1016/j.heliyon.2019.e02249}
|
|---|---|---|
|
Overall Study
incomplete data on file
|
245
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Group
n=405 Participants
Randomly selected data of 405 patients treated within the last ten years at the study site.
|
Dakahlia Governorate Adult Female Population
n=145 Participants
A historical control group derived from the raw data of a previously published study (PMID: 31463388, PMCID: PMC6709406, DOI: 10.1016/j.heliyon.2019.e02249)
|
Total
n=550 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 years
|
127 Participants
n=405 Participants
|
93 Participants
n=145 Participants
|
220 Participants
n=550 Participants
|
|
Age, Customized
45 years or above
|
278 Participants
n=405 Participants
|
52 Participants
n=145 Participants
|
330 Participants
n=550 Participants
|
|
Sex: Female, Male
Female
|
405 Participants
n=405 Participants
|
145 Participants
n=145 Participants
|
550 Participants
n=550 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=405 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=550 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Egypt
|
405 participants
n=405 Participants
|
145 participants
n=145 Participants
|
550 participants
n=550 Participants
|
PRIMARY outcome
Timeframe: This outcome will be assessed through study completion, an average of 6 months.Percentage of patients with breast cancer with positive anti-HCV serological test.
Outcome measures
| Measure |
Study Group
n=405 Participants
Randomly selected data of 405 patients treated within the last ten years at the study site.
|
Dakahlia Governorate Adult Female Population
n=145 Participants
One-hundred forty-five adult females from Dakahlia governorate were sampled in a published population-based cross sectional study from 2015 to 2017.
|
|---|---|---|
|
Prevalence of HCV Seropositivity in Breast Cancer Patients.
anti-HCV Seropositive
|
88 Participants
|
15 Participants
|
|
Prevalence of HCV Seropositivity in Breast Cancer Patients.
anti-HCV seronegative
|
317 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: at the date of last patients' visit recorded on her file. Patients should be censored at least 12 months from the time of diagnosis.Population: At the time of analysis, median survival has not been reached. This Outcome Measure was pre-specified to be collected only for the Study Group. The outcome is not applicable to the control group (non-cancer population).
The number of events related to breast cancer diagnosis. Disease-free survival (DFS) was calculated as the time from the date of breast cancer diagnosis to the date of last follow-up or the date of first breast cancer-related event. At the time of analysis, median survival has not been reached.
Outcome measures
| Measure |
Study Group
n=88 Participants
Randomly selected data of 405 patients treated within the last ten years at the study site.
|
Dakahlia Governorate Adult Female Population
n=317 Participants
One-hundred forty-five adult females from Dakahlia governorate were sampled in a published population-based cross sectional study from 2015 to 2017.
|
|---|---|---|
|
Disease-related Events
|
37 number of events related to cancer
|
6 number of events related to cancer
|
Adverse Events
Study Group
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
- Publication restrictions are in place