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

Tracking Information
First Submitted Date	September 19, 2011
First Posted Date	December 2, 2011
Last Update Posted Date	February 16, 2018
Actual Study Start Date	August 8, 2011
Estimated Primary Completion Date	October 19, 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: November 30, 2011)	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 ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01484483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: November 30, 2011)	Progression-free survival [ Time Frame: 5 years ]; Overall survival [ Time Frame: 5 years ]; Patient demographics of breast cancer patients in Kenya [ Time Frame: 5 years ]; Pathology: Prevalence of tumour types [ Time Frame: 5 years ]; Correlation between risk factors and clinical outcome [ Time Frame: 5 years ]; Therapy duration/compliance [ Time Frame: 5 years ]; Safety: Incidence of adverse events [ Time Frame: 5 years ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya
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
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Newly diagnosed breast cancer patients
Condition	Breast Cancer
Intervention	Not Provided
Study Groups/Cohorts	Cohort
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Active, not recruiting
Actual Enrollment; (submitted: March 7, 2017)	367
Original Estimated Enrollment; (submitted: November 30, 2011)	410
Estimated Study Completion Date	October 19, 2020
Estimated Primary Completion Date	October 19, 2020 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Kenya
Removed Location Countries
Administrative Information
NCT Number	NCT01484483
Other Study ID Numbers	ML25502
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Hoffmann-La Roche
Study Sponsor	Hoffmann-La Roche
Collaborators	Not Provided
Investigators	Study Director: Clinical Trials Hoffmann-La Roche
PRS Account	Hoffmann-La Roche
Verification Date	February 2018