An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01484483

ML25502

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Cohort