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Completed

NCT Number: NCT01484483

An Observational Study to Register the Incidence 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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Nairobi School of Medicine; Internal Medicine and Therapeutics

Nairobi, 00202, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2011
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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