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Recruiting NCT05044689

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

Observational Colorectal Cancer Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire, Bioimpedance/Body Composition Unit.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Breast Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Nigeria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Development and Validation of Questionnaire For Assessing Modifiable Risk Factors for Cancer in Sub-Saharan Africa [Time frame: 2 years]
  • Determination of Novel Modifiable Cancer Risk Factors in a Nigerian Population [Time frame: 2 years]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Nigeria · 1 center
  • Obafemi Awolowo University Teaching Hospitals — Ile-Ife

Identifiers

NCT: NCT05044689 · ERC/2018/06/01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗