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Clinical Trials/NCT01484483
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

Hoffmann-La Roche1 site in 1 country400 target enrollmentAugust 8, 2011
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.

Registry
clinicaltrials.gov
Start Date
August 8, 2011
End Date
December 6, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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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