Case Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria

NCT ID: NCT05044689

Last Updated: 2025-03-21

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

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-12

Study Completion Date

2026-12-31

Brief Summary

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This project is a case-control study which seeks to identify modifiable risk factors for breast and colorectal cancer in Nigeria. Both cases and controls will be required to complete a risk factor questionnaire which contains information about their diet, physical activity, past medical history and life style factors. They will also be required to provide information on their body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water percentage.

Based on the existing ARGO platform where a current colorectal cancer study is going on, approximately 400 patients with a prior diagnosis or a new diagnosis will be recruited into this study. Comparatively, we will select our 400 controls from two groups of participants who are free of cancer and gastrointestinal diseases.

Detailed Description

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Conditions

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Colorectal Cancer Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Colorectal Cancer (Cases)

Based on the existing ARGO (African Colorectal Cancer Group) platform where a current colorectal cancer study is going on, 400 patients with a prior diagnosis and a new diagnosis will be recruited into this study.

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.

Bioimpedance/Body Composition Unit

Intervention Type DEVICE

Patients will provide information on body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water.

Controls

We will select our 400 controls from two groups of participants who are free of cancer and gastrointestinal diseases. First, we will leverage community mobilization groups to identify and recruit a target group of 200 community-based population controls. Second, we will identify and recruit the remaining 200 controls from those seeking care in the Outpatient Health Center at OAU, which sees \~50-60 patients per day as part of routine care.

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.

Bioimpedance/Body Composition Unit

Intervention Type DEVICE

Patients will provide information on body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water.

Interventions

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Questionnaire

Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.

Intervention Type BEHAVIORAL

Bioimpedance/Body Composition Unit

Patients will provide information on body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Case Group - Patients must have histologically confirmed diagnosis of colorectal or breast cancer.

Control Group - Patients must not have a diagnosis of cancer.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

Lagos State University

OTHER

Sponsor Role collaborator

University of Ilorin Teaching Hospital

OTHER

Sponsor Role collaborator

Federal Medical Centre, Owo

INDUSTRY

Sponsor Role collaborator

University of Maiduguri Teaching Hospital

UNKNOWN

Sponsor Role collaborator

National Hospital, Abuja

OTHER_GOV

Sponsor Role collaborator

Obafemi Awolowo University Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olusegun Alatise

MB.ChB (Ife), M.Sc, FWACS, FMCS, FACS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Obafemi Awolowo University Teaching Hospitals

Ile-Ife, Osun State, Nigeria

Site Status RECRUITING

Countries

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Nigeria

Facility Contacts

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Olusegun I Alatise, FWACS

Role: primary

2348033859387

Other Identifiers

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ERC/2018/06/01

Identifier Type: -

Identifier Source: org_study_id

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