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NCT05044689 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05044689
Other study ID # ERC/2018/06/01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 12, 2021
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source Obafemi Awolowo University Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 800
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Case Group - Patients must have histologically confirmed diagnosis of colorectal or breast cancer. Control Group - Patients must not have a diagnosis of cancer.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Nigeria Obafemi Awolowo University Teaching Hospitals Ile Ife Osun

Sponsors (7)
Lead Sponsor Collaborator
Obafemi Awolowo University Teaching Hospital Federal Medical Centre, Owo, Lagos State University, Memorial Sloan Kettering Cancer Center, National Hospital, Abuja, University of Ilorin Teaching Hospital, University of Maiduguri Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development and Validation of Questionnaire For Assessing Modifiable Risk Factors for Cancer in Sub-Saharan Africa 2 years
Primary 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
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