Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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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 March 2015 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01484483
First received: September 19, 2011
Last updated: March 2, 2015
Last verified: March 2015
History of Changes

September 19, 2011
March 2, 2015
August 2011
October 2018   (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
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Newly diagnosed breast cancer patients
Breast Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
410
October 2018
October 2018   (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
No
Contact: Reference Study ID Number: ML25502 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Kenya
 
NCT01484483
ML25502
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2015

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