The Ghana Breast Health Study

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT01661023
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Background:

- Breast cancer is becoming more common in Africa. A higher number of cases appear in women under age 35 than in the developed world. However, little is known about the factors that may contribute to breast cancer in Africa. Researchers want to collect information from female patients in teaching hospitals in Accra and Kumasi, Ghana and to compare this information with that obtained from healthy women in the general population. These two hospitals treat most breast cancers in Ghana. The data will provide information regarding factors that predispose to the development of breast cancer among women in Ghana.

Objectives:

- To identify and study breast cancer risk factors in women in Ghana.

Eligibility:

* Women between 18 and 74 years of age who are diagnosed with breast cancer.

* Participants will come from teaching hospitals in Accra and Kumasi, Ghana. Women without breast cancer will be identified from the 2010 Ghanaian Census for comparison purposes

Design:

* Participants will answer questions about their health and lifestyle.

* Height, weight, and waist/hip measurements will be collected.

* Blood and saliva samples will be collected.

* Participants will be given a collection kit to collect a stool sample.

* Treatment will not be provided as part of this study.

Detailed Description

Breast cancer is becoming a more common disease in Africa, with a high proportion of cases developing among women under age 50. Despite this, there is scant information on predisposing factors in African populations. We are proposing a multidisciplinary case-control study at three hospitals in Accra and Kumasi that treat the majority of breast cancers in Ghana. We have begun this investigation as a pilot endeavor and are seeking approval for continuation into a full-scale effort, which over the two years following the pilot will result in a total of approximately 2,000 interviewed cases and 2,000 population controls. Tumor tissue samples are being sought from cases in order to classify them into subtypes (including triple negative tumors, which predominate among young African women). A detailed questionnaire is being administered in hospital and anthropometry measurements are being taken. Additionally, subjects are being asked to donate blood, saliva, and stool samples for assessment of genetic and other biologic markers. Similar materials are being collected from population controls. In addition to providing unique data relevant for improving prevention activities, this study will build capacity for additional research activities in Ghana.

Study Timeline

• Study Start: 2012-07-19
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-07
• Study First Posted: 2012-08-09
• Primary Completion: 2016-04-25
• Status Verified: 2020-04
• Study Completion: 2020-04-16
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4241

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast Cancer	Within one year of diagnosis	Pathologically confirmed diagnosis of breast cancer

Secondary Outcome Measures

Name	Time	Method
Benign breast disease	At biopsy

Trial Locations

Locations (2)

University of Ghana; 🇬🇭 Accra, Ghana

Kwane Nkrumah University of Science and Technology; 🇬🇭 Kumasi, Ghana