Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hepatitis C viral infection is a major health problem in Egypt. The management of breast cancer patients is often complicated by the presence of associated HCV infection. This study aims at investigating the epidemiological association of the two conditions. It will also investigate the possible correlation with treatment outcome.
Breast cancer is the most common cancer in adult Egyptian females. The world's highest prevalence of hepatitis C virus is found in Egypt. Several investigators examined the epidemiological association of HCV with breast cancer. Published literature reports conflicting results regarding the HCV association with breast cancer incidence. Population-based studies from HCV-endemic area demonstrated increased breast cancer incidence in HCV-positive women younger than 50 years. On the other hand, population studies from HCV-low prevalence regions failed to detect an association of the virus with breast cancer.
HCV seropositive patients constitute a large sector of oncology patients treated in Egyptian practice. HCV infection with or without clinically-significant liver disease impose several therapeutic, social and logistic problems. Recently, investigators from Mansoura University reported their findings among breast cancerpatients. According to these data, HCV-positive breast cancer patients had several markers of disease aggression such as large tumor size, high tumor grade and nodal infiltration. Moreover, HCV-NS4 (non-structural protein-4) blood levels positively correlated with the level of the known breast cancer marker CA15-3.
In the current study, the investigators will investigate the incidence of HCV seropositivity in breast cancer patients and an age-matched control group. The study also examines the association of HCV status on the patients' baseline characteristics such as tumor stage and grade and with patients' treatment plan and treatment outcome.
Specifically, the aims of the study are the following:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| Control group | A group of age-matched women from the same geographical distribution who are healthy volunteers or hospital patients without cancer diagnosis will serve as a control group for the HCV prevalence. We aim at a sample size with a study-to-control ratio of 1:3. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of HCV Seropositivity in Breast Cancer Patients. | Percentage of patients with breast cancer with positive anti-HCV serological test. | This outcome will be assessed through study completion, an average of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-related Events | 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. | at the date of last patients' visit recorded on her file. Patients should be censored at least 12 months from the time of diagnosis. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Retrospective analysis of all consecuitive patients on Oncology Center of Mansoura University (OCMU) database.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Oncology Center | Al Mansurah | DK | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22115285 | Background | Su FH, Chang SN, Chen PC, Sung FC, Su CT, Yeh CC. Association between chronic viral hepatitis infection and breast cancer risk: a nationwide population-based case-control study. BMC Cancer. 2011 Nov 24;11:495. doi: 10.1186/1471-2407-11-495. | |
| 29285674 | Background | Attallah AM, El-Far M, Abdelrazek MA, Omran MM, Mahmoud AZ, Khalifa HS, Ahmed MM, El-Dosoky I. HCV nonstructural protein 4 is associated with aggressiveness features of breast cancer. Breast Cancer. 2018 May;25(3):297-302. doi: 10.1007/s12282-017-0829-1. Epub 2017 Dec 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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}](streamdown:incomplete-link) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Randomly selected data of 405 patients treated within the last ten years at the study site. |
| BG001 | Dakahlia Governorate Adult Female Population | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of HCV Seropositivity in Breast Cancer Patients. | Percentage of patients with breast cancer with positive anti-HCV serological test. | Posted | Count of Participants | Participants | This outcome will be assessed through study completion, an average of 6 months. |
|
All-cause Mortality and Adverse Events were not assessed in this Retrospective, observational study.
All-cause Mortality and Adverse Events were not assessed in this retrospective, observational study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | All-cause Mortality and Adverse Events were not assessed in this retrospective, observational study |
Not provided
Not provided
This is a retrospective study. Due to limited funding, a non-selected sample of Breast Cancer was compared to a historical control derived from the data of a previously published population study. Further studies are required.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Osama Hussein | Mansoura University | 00201099815110 | osamahussein@mans.edu.eg |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 | Sep 24, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 31463388 | Background | El-Ghitany EM, Farghaly AG. Geospatial epidemiology of hepatitis C infection in Egypt 2017 by governorate. Heliyon. 2019 Aug 17;5(8):e02249. doi: 10.1016/j.heliyon.2019.e02249. eCollection 2019 Aug. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Disease-related Events | 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. | 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). | Posted | Number | number of events related to cancer | at the date of last patients' visit recorded on her file. Patients should be censored at least 12 months from the time of diagnosis. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |