NCT01484483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

8.3 years

First QC Date

September 19, 2011

Last Update Submit

December 19, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of breast cancer in Kenya

    5 years

  • Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya

    5 years

Secondary Outcomes (7)

  • Progression-free survival

    5 years

  • Overall survival

    5 years

  • Patient demographics of breast cancer patients in Kenya

    5 years

  • Pathology: Prevalence of tumour types

    5 years

  • Correlation between risk factors and clinical outcome

    5 years

  • +2 more secondary outcomes

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Newly diagnosed breast cancer patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nairobi School of Medicine; Internal Medicine and Therapeutics

Nairobi, 00202, Kenya

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

December 2, 2011

Study Start

August 8, 2011

Primary Completion

December 6, 2019

Study Completion

December 6, 2019

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations

KE(1)