NCT01484483
Completed
Not Applicable
Breast Cancer Care (BRECC) Registry - Development of a Breast Cancer Registry to Determine the Magnitude of Breast Cancer and Current Clinical Care Patterns in Kenya
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Incidence of breast cancer in Kenya
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed breast cancer
- •No previous interventional therapy for breast cancer
- •Ability to provide written informed consent as per GCP and local regulations
Exclusion Criteria
- •Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment
- •Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse
Outcomes
Primary Outcomes
Incidence of breast cancer in Kenya
Time Frame: 5 years
Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya
Time Frame: 5 years
Secondary Outcomes
- Progression-free survival(5 years)
- Overall survival(5 years)
- Pathology: Prevalence of tumour types(5 years)
- Patient demographics of breast cancer patients in Kenya(5 years)
- Correlation between risk factors and clinical outcome(5 years)
- Therapy duration/compliance(5 years)
- Safety: Incidence of adverse events(5 years)
Study Sites (1)
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