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

Recruiting

• Conditions: Colorectal Cancer; Breast Cancer
• Interventions: Behavioral: Questionnaire; Device: Bioimpedance/Body Composition Unit

• Registration Number: NCT05044689
• Lead Sponsor: Obafemi Awolowo University Teaching Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-04-12
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal Cancer (Cases)	Questionnaire	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.
Colorectal Cancer (Cases)	Bioimpedance/Body Composition Unit	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.
Controls	Questionnaire	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.
Controls	Bioimpedance/Body Composition Unit	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.

Primary Outcome Measures

Name	Time	Method
Development and Validation of Questionnaire For Assessing Modifiable Risk Factors for Cancer in Sub-Saharan Africa	2 years
Determination of Novel Modifiable Cancer Risk Factors in a Nigerian Population	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

Trial Locations

Locations (1)

Obafemi Awolowo University Teaching Hospitals; 🇳🇬 Ile Ife, Osun, Nigeria