NCT01661023

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

July 19, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

August 7, 2012

Last Update Submit

April 16, 2020

Conditions

Keywords

Breast CancerEpidemiology

Outcome Measures

Primary Outcomes (1)

  • Breast Cancer

    Pathologically confirmed diagnosis of breast cancer

    Within one year of diagnosis

Secondary Outcomes (1)

  • Benign breast disease

    At biopsy

Eligibility Criteria

Age18 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The source of breast cancer cases included the two largest teaching/cancer treatment hospitals in the country, Korle Bu Teaching Hospital in Accra and Komfo Anoyke Teaching Hospital in Kumasi, as well as Peace and Love Hospital, a private hospital in Kumasi that specializes in breast cancer care and diagnoses and treats a large number of breast cancer patients. Eligibility criteria for study cases included being recommended for a biopsy given lesions suspicious of malignancy or presenting at a @@@study hospital for treatment of pathologically documented breast cancers diagnosed within the preceding year.Controls were selected from women in the catchment area of the hospitals using data from the 2010 Census, matched on age and geographical area to the the cases.@@@@@@

* 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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

University of Ghana

Accra, Ghana

Location

Kwane Nkrumah University of Science and Technology

Kumasi, Ghana

Location

Related Publications (3)

  • 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.

    PMID: 19704069BACKGROUND
  • 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.

    PMID: 21172092BACKGROUND
  • 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.

    PMID: 15067980BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Montserrat Garcia-Closas, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 9, 2012

Study Start

July 19, 2012

Primary Completion

April 25, 2016

Study Completion

April 16, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations