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

Study Overview
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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.

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

Conditions
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Colorectal Cancer, Breast Cancer

Intervention / Treatment
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* Behavioral: Questionnaire
* Device: Bioimpedance/Body Composition Unit


Participation Criteria
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Eligibility Criteria
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Case Group - Patients must have histologically confirmed diagnosis of colorectal or breast cancer. Control Group - Patients must not have a diagnosis of cancer.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal Cancer (Cases)<br>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<br>* Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.<br>Device: Bioimpedance/Body Composition Unit<br>* 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.<br>|
| Controls<br>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<br>* Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.<br>Device: Bioimpedance/Body Composition Unit<br>* 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.<br>|

What is the study measuring?
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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 |  | 2 years | 
| Determination of Novel Modifiable Cancer Risk Factors in a Nigerian Population | 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 |