We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01484483
First Posted: December 2, 2011
Last Update Posted: August 22, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 367
Actual Study Start Date: August 8, 2011
Estimated Study Completion Date: October 19, 2020
Estimated Primary Completion Date: October 19, 2020 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed breast cancer patients
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01484483


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01484483     History of Changes
Other Study ID Numbers: ML25502
First Submitted: September 19, 2011
First Posted: December 2, 2011
Last Update Posted: August 22, 2017
Last Verified: August 2017

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