Colorectal CancerNCT03032874
Community Based Screening for Colorectal Cancer in an Underserved High Risk Population in Nigeria
An observational study of Colorectal Cancer, run by Obafemi Awolowo University Teaching Hospital at 1 site in Nigeria.
Trial summary
Patient age 45 year old and above who presented with rectal bleeding at three tertiary hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the patients and the colonoscopy data were analyzed Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jan 2014to 30 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nigerians with rectal bleeding
Who may be able to join
- must be 45-years of age or older
- has rectal bleeding lasting at least one week
- has had a complete colonoscopy performed
Who cannot join
- Individuals with a personal history of inflammatory bowel disease, colorectal polyps, colorectal adenoma or CRC
- Individuals with a family history of familial adenomatous polyposis syndromes or other hereditary polyposis syndromes, hereditary nonpolyposis colorectal cancer
- Individuals with severe comorbidities that were contraindication to colonoscopy
- Individuals who had a previous history of colectomy
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals
Ile-Ife, Osun State, 220005
About this study
Official title: Colorectal Cancer Control in Low Resource Countries: Results From a Prospective Cohort Study of Patients at High-risk for Colorectal Cancer
Patient age 45 year old and above who presented with rectal bleeding at three tertiary hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the patients and the colonoscopy data were analyzed
Read the detailed description
Patient age 45 year old and above who presented with rectal bleeding at Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Nigeria, University College Hospital, Ibadan, Nigeria, and University of Ilorin Teaching Hospital, Ilorin Nigeria were invited for colonoscopy. Categorical variables were compared using χ2-test or Fisher's exact test while the Kruskal-Wallis test was used for quantitative variables. Multivariate analysis was performed using logistic regression model. All statistical tests were two-sided and p-values below 0.05 were considered statistically significant. Statistical analysis was carried out using SAS 9.4 and R 3.3.1.
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopy
- Keywords
- Colorectal cancer, Polyps, Colonoscopy, Rectal bleeding, Nigeria
- Medical subject headings
- Colorectal Neoplasms, Polyps, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
They all had screening colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Training set | All the patients with rectal bleeding who had colonoscopy performed at Obafemi Awolowo University Teaching Hospitals Complex Receives: Procedure: Colonoscopy | |
| Validation set | All the patients with rectal bleeding who had colonoscopy performed at University College Hospital, Ibadan and University of Ilorin Teaching Hospital Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine colonoscopy polyp and cancer detection rate
The hypothesis for this study was that colonoscopy surveillance of a high-risk cohort of patients with rectal bleeding would demonstrate that 10-20% of these patients have pre-malignant colorectal polyps(adenomas) or cancers.
Measured: 2 years
Secondary outcomes (1)
To detect colorectal cancer early using symptoms based assessment
The long-term impact of identifying at risk patients and patients with early stage cancers may be a reduction in mortality from colorectal cancer in low- and middle- income countries
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 posted26 Jan 2017 (estimated)
- Study start1 Jan 2014
- Primary completion30 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University Teaching Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, University College Hospital, Nigeria, University of Ilorin Teaching Hospital
- Responsible party
- Principal investigator, Olusegun Alatise, Obafemi Awolowo University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032874
- Sponsor's protocol ID
- ERC/2013/02/07
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Each request will be review on their merit by the team and approval of the Ethic and Research Committee that approve the study
Publications
Alatise OI, Ayandipo OO, Adeyeye A, Seier K, Komolafe AO, Bojuwoye MO, Afuwape OO, Zauber A, Omisore A, Olatoke S, Akere A, Famurewa O, Gonen M, Irabor DO, Kingham TP. A symptom-based model to predict colorectal cancer in low-resource countries: Results from a prospective study of patients at high risk for colorectal cancer. Cancer. 2018 Jul 1;124(13):2766-2773. doi: 10.1002/cncr.31399. Epub 2018 Apr 12.
PubMed 29645077
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Control in Low Resource Countries: Results From a Prospective Cohort Study of Patients at High-risk for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03032874
- Acronym / sponsor ID
- ERC/2013/02/07
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Polyps, Colonoscopy, Rectal bleeding, Nigeria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Obafemi Awolowo University Teaching HospitalUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, University College Hospital, Nigeria, University of Ilorin Teaching Hospital
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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.
Patient age 45 year old and above who presented with rectal bleeding at three tertiary hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the patients and the colonoscopy data were analyzed
Detailed description
Patient age 45 year old and above who presented with rectal bleeding at Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Nigeria, University College Hospital, Ibadan, Nigeria, and University of Ilorin Teaching Hospital, Ilorin Nigeria were invited for colonoscopy. Categorical variables were compared using χ2-test or Fisher's exact test while the Kruskal-Wallis test was used for quantitative variables. Multivariate analysis was performed using logistic regression model. All statistical tests were two-sided and p-values below 0.05 were considered statistically significant. Statistical analysis was carried out using SAS 9.4 and R 3.3.1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training set | – | Procedure: ColonoscopyAll the patients with rectal bleeding who had colonoscopy performed at Obafemi Awolowo University Teaching Hospitals Complex |
| Validation set | – | Procedure: ColonoscopyAll the patients with rectal bleeding who had colonoscopy performed at University College Hospital, Ibadan and University of Ilorin Teaching Hospital |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nigerians with rectal bleeding
Key inclusion criteria (3 listed)
- must be 45-years of age or older
- has rectal bleeding lasting at least one week
- has had a complete colonoscopy performed
Key exclusion criteria (4 listed)
- Individuals with a personal history of inflammatory bowel disease, colorectal polyps, colorectal adenoma or CRC
- Individuals with a family history of familial adenomatous polyposis syndromes or other hereditary polyposis syndromes, hereditary nonpolyposis colorectal cancer
- Individuals with severe comorbidities that were contraindication to colonoscopy
- Individuals who had a previous history of colectomy
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 |
|---|---|---|
| ColonoscopyThey all had screening colonoscopy | Procedure or surgery | Training set, Validation set |
Primary outcome
To determine colonoscopy polyp and cancer detection rate
Time frame: 2 years
The hypothesis for this study was that colonoscopy surveillance of a high-risk cohort of patients with rectal bleeding would demonstrate that 10-20% of these patients have pre-malignant colorectal polyps(adenomas) or cancers.
1 secondary outcome
To detect colorectal cancer early using symptoms based assessment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Derived from this study: PubMed 29645077Alatise OI, Ayandipo OO, Adeyeye A, Seier K, Komolafe AO, Bojuwoye MO, Afuwape OO, Zauber A, Omisore A, Olatoke S, Akere A, Famurewa O, Gonen M, Irabor DO, Kingham TP. A symptom-based model to predict colorectal cancer in low-resource countries: Results from a prospective study of patients at high risk for colorectal cancer. Cancer. 2018 Jul 1;124(13):2766-2773. doi: 10.1002/cncr.31399. Epub 2018 Apr 12.
- Individual participant dataSharing planned: Undecided. Each request will be review on their merit by the team and approval of the Ethic and Research Committee that approve the study
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, 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.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine colonoscopy polyp and cancer detection rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032874, which also lists 1 linked publication.
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 30 Jan 2017.