Colorectal CancerNCT05044689
Case Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria
An observational study of Colorectal Cancer and Breast Cancer, run by Obafemi Awolowo University Teaching Hospital at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Breast Cancer
- What is being tested?
- Questionnaire and Bioimpedance/Body Composition Unit
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 1 siteNigeria
- Study dates
- 12 Apr 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site, 1 recruiting
- Recruiting
Obafemi Awolowo University Teaching Hospitals
Ile-Ife, Osun State, 220005
Olusegun I Alatise, FWACS, 2348033859387, segunalatishe@gmail.com
About this study
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
- Being tested
- Questionnaire, Bioimpedance/Body Composition Unit
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.
Bioimpedance/Body Composition UnitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Questionnaire; Device: Bioimpedance/Body Composition Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and Validation of Questionnaire For Assessing Modifiable Risk Factors for Cancer in Sub-Saharan Africa
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start12 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Lagos State University, University of Ilorin Teaching Hospital, Federal Medical Centre, Owo, University of Maiduguri Teaching Hospital, National Hospital, Abuja
- Responsible party
- Principal investigator, Olusegun Alatise, Obafemi Awolowo University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044689
- Sponsor's protocol ID
- ERC/2018/06/01
- Status last verified
- Mar 2025
- First submitted
- 9 Sep 2021
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria
- ClinicalTrials.gov ID
- NCT05044689
- Acronym / sponsor ID
- ERC/2018/06/01
- Conditions
- Colorectal Cancer, Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Obafemi Awolowo University Teaching HospitalUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Lagos State University, University of Ilorin Teaching Hospital, Federal Medical Centre, Owo, University of Maiduguri Teaching Hospital, National Hospital, Abuja
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer (Cases) | – | Behavioral: Questionnaire, Device: Bioimpedance/Body Composition UnitBased 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 | – | Behavioral: Questionnaire, Device: Bioimpedance/Body Composition UnitWe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire containing questions regarding diet, physical activity, past medical history and life style practices. | Behavioural | Colorectal Cancer (Cases), Controls |
| Bioimpedance/Body Composition UnitPatients will provide information on body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water. | Device | Colorectal Cancer (Cases), Controls |
Primary outcome
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
We will determine the presence of established, plausible, and novel cancer risk factors in cases (n=400) and controls (n=400) in Nigeria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Breast Cancer, run by Obafemi Awolowo University Teaching Hospital at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and Validation of Questionnaire For Assessing Modifiable Risk Factors for Cancer in Sub-Saharan Africa (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.