An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya
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ClinicalTrials.gov Identifier: NCT01484483 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 2, 2011
Last Update Posted
: February 16, 2018
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | ||||
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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 |
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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 |
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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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Actual Enrollment |
367 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Hoffmann-La Roche | |||
Verification Date | February 2018 |