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

March 18, 2025 updated by: Olusegun Alatise, Obafemi Awolowo University Teaching Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Osun
      • Ile Ife, Osun, Nigeria, 220005
        • Recruiting
        • Obafemi Awolowo University Teaching Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Based on the existing African Research Group for Oncology platform where a current colorectal study is going on, 400 patients with a prior diagnosis and a new diagnosis of colorectal cancer or breast cancer will be recruited into this study.

A combined total of 400 controls will be recruited from community mobilization groups and the Outpatient Health Center at OAU who are free of cancer and gastrointestinal diseases.

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: Questionnaire
Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.
Device: 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.
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.
Behavioral: Questionnaire
Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development and Validation of Questionnaire For Assessing Modifiable Risk Factors for Cancer in Sub-Saharan Africa
Time Frame: 2 years
2 years
Determination of Novel Modifiable Cancer Risk Factors in a Nigerian Population
Time Frame: 2 years
We will determine the presence of established, plausible, and novel cancer risk factors in cases (n=400) and controls (n=400) in Nigeria
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obafemi Awolowo University Teaching Hospital

Collaborators

Memorial Sloan Kettering Cancer Center
Lagos State University
Federal Medical Centre, Owo
National Hospital, Abuja
University of Ilorin Teaching Hospital
University of Maiduguri Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC/2018/06/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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