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

NCT05044689 | Recruiting

• 1 other identifier: ERC/2018/06/01
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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; Device: Bioimpedance/Body Composition Unit

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; Device: Bioimpedance/Body Composition Unit

Interventions

Questionnaire BEHAVIORAL

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

Colorectal Cancer (Cases); Controls

Bioimpedance/Body Composition Unit 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.

Colorectal Cancer (Cases); Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

Case Group - Patients must have histologically confirmed diagnosis of colorectal or breast cancer. Control Group - Patients must not have a diagnosis of cancer.

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

Sponsors & Collaborators

• Obafemi Awolowo University Teaching Hospital: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• Lagos State University: collaborator
• University of Ilorin Teaching Hospital: collaborator
• Federal Medical Centre, Owo: collaborator
• University of Maiduguri Teaching Hospital: collaborator
• National Hospital, Abuja: collaborator

Study Sites (1)

Obafemi Awolowo University Teaching Hospitals

Ile-Ife, Osun State, 220005, Nigeria

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MB.ChB (Ife), M.Sc, FWACS, FMCS, FACS

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 16, 2021
• Study Start: April 12, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)