The Ghana Breast Health Study

NCT ID: NCT01661023

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-19

Study Completion Date

2020-04-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Montserrat Garcia-Closas, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Ghana

Accra, , Ghana

Site Status

Kwane Nkrumah University of Science and Technology

Kumasi, , Ghana

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ghana

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19704069 (View on PubMed)

Akarolo-Anthony SN, Ogundiran TO, Adebamowo CA. Emerging breast cancer epidemic: evidence from Africa. Breast Cancer Res. 2010 Dec 20;12 Suppl 4(Suppl 4):S8. doi: 10.1186/bcr2737. No abstract available.

Reference Type BACKGROUND
PMID: 21172092 (View on PubMed)

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. doi: 10.1177/146642400412400212.

Reference Type BACKGROUND
PMID: 15067980 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-C-N174

Identifier Type: -

Identifier Source: secondary_id

999912174

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Breast Cancer Prevention Education
NCT01299623 COMPLETED NA
Tumour Registry Breast Cancer
NCT01351584 COMPLETED
Hong Kong Breast Cancer Study
NCT02889458 ACTIVE_NOT_RECRUITING
Susceptibility to Breast Cancer
NCT00004565 COMPLETED