The Ghana Breast Health Study

Breast Neoplasms Clinical Trial

Official title:

A Multidisciplinary Study of Breast Cancer in Ghana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661023
• Other study ID #: 999912174
• Secondary ID: 12-C-N174
• Status: Completed
• Start date: July 19, 2012
• Est. completion date: April 16, 2020

Study information

• Verified date: April 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4241
• Est. completion date: April 16, 2020
• Est. primary completion date: April 25, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 74 Years

Eligibility

• ELIGIBILITY CRITERIA:

Eligible for inclusion as cases in this study will be women 18-74 years of age who have been residents of defined catchment areas surrounding the two cities for at least one year s time and who are either diagnosed at the study hospitals within the past year (KBTH, KATH, and PLH) or referred there for clinical care. The catchment area in Accra will consist of 10 districts in Greater Accra (Accra Metropolitan, Adenta, Tema, Ashaiman, Ga East, Ga West, Ledzokuku-Krowor, Weija (Ga South), Dangbe East, Dangbe West), two in the Eastern region (Suhum Kraboa Coaltar, Akwapim South) and one in the Central region (Awutu Senya). In Kumasi, the catchment area will consist of 7 districts surrounding KATH and PLH (Atwima Kwanwoma, Atwima Nwabiagya, Bosumtwi, Ejisu Juaben, Afigya Kwabre, Kwabre, and Kumasi Metropolitan).

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Ghana	University of Ghana	Accra
Ghana	Kwane Nkrumah University of Science and Technology	Kumasi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

Ghana, 

References & Publications (3)

Akarolo-Anthony SN, Ogundiran TO, Adebamowo CA. Emerging breast cancer epidemic: evidence from Africa. Breast Cancer Res. 2010 Dec 20;12 Suppl 4:S8. doi: 10.1186/bcr2737. — View Citation

Huo D, Ikpatt F, Khramtsov A, Dangou JM, Nanda R, Dignam J, Zhang B, Grushko T, Zhang C, Oluwasola O, Malaka D, Malami S, Odetunde A, Adeoye AO, Iyare F, Falusi A, Perou CM, Olopade OI. Population differences in breast cancer: survey in indigenous African women reveals over-representation of triple-negative breast cancer. J Clin Oncol. 2009 Sep 20;27(27):4515-21. doi: 10.1200/JCO.2008.19.6873. Epub 2009 Aug 24. — View Citation

Walker AR, Adam FI, Walker BF. Breast cancer in black African women: a changing situation. J R Soc Promot Health. 2004 Mar;124(2):81-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast Cancer	Pathologically confirmed diagnosis of breast cancer	Within one year of diagnosis
Secondary	Benign breast disease		At biopsy