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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01484483
First received: September 19, 2011
Last updated: September 1, 2016
Last verified: September 2016
History of Changes

September 19, 2011
September 1, 2016
August 2011
October 2020   (final data collection date for primary outcome measure)
  • Incidence of breast cancer in Kenya [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01484483 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Patient demographics of breast cancer patients in Kenya [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Pathology: Prevalence of tumour types [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Correlation between risk factors and clinical outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Therapy duration/compliance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
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An Observational Study to Register the Incidence of Breast Cancer and Current Clinical Care Patterns in Kenya
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
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Newly diagnosed breast cancer patients
Breast Cancer
Not Provided
Cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
410
October 2020
October 2020   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact: Reference Study ID Number: ML25502 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com
Kenya
 
NCT01484483
ML25502
Not Provided
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP