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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484483
• Other study ID #: ML25502
• Status: Completed
• Start date: August 8, 2011
• Est. completion date: December 6, 2019

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 6, 2019
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Kenya	University of Nairobi School of Medicine; Internal Medicine and Therapeutics	Nairobi

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of breast cancer in Kenya		5 years
Primary	Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya		5 years
Secondary	Progression-free survival		5 years
Secondary	Overall survival		5 years
Secondary	Patient demographics of breast cancer patients in Kenya		5 years
Secondary	Pathology: Prevalence of tumour types		5 years
Secondary	Correlation between risk factors and clinical outcome		5 years
Secondary	Therapy duration/compliance		5 years
Secondary	Safety: Incidence of adverse events		5 years