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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01484483
Recruitment Status : Active, not recruiting
First Posted : December 2, 2011
Last Update Posted : February 11, 2019
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease
Breast Cancer

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Study Type : Observational
Actual Enrollment : 367 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 8, 2011
Estimated Primary Completion Date : October 19, 2020
Estimated Study Completion Date : October 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Primary Outcome Measures :
  1. Incidence of breast cancer in Kenya [ Time Frame: 5 years ]
  2. Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 5 years ]
  2. Overall survival [ Time Frame: 5 years ]
  3. Patient demographics of breast cancer patients in Kenya [ Time Frame: 5 years ]
  4. Pathology: Prevalence of tumour types [ Time Frame: 5 years ]
  5. Correlation between risk factors and clinical outcome [ Time Frame: 5 years ]
  6. Therapy duration/compliance [ Time Frame: 5 years ]
  7. Safety: Incidence of adverse events [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed breast cancer patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01484483

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University of Nairobi School of Medicine; Internal Medicine and Therapeutics
Nairobi, Kenya, 00202
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01484483     History of Changes
Other Study ID Numbers: ML25502
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases