Clinical trial NCT03032874: Community Based Screening for Colorectal Cancer in an Underserved High Risk Population in Nigeria
Official title: Colorectal Cancer Control in Low Resource Countries: Results From a Prospective Cohort Study of Patients at High-risk for Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Polyps
Colonoscopy
Rectal bleeding
Nigeria
Lead sponsor: Obafemi Awolowo University Teaching Hospital
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center, New York, USA
name: University College Hospital, Nigeria
name: University of Ilorin Teaching Hospital
First posted: 2017-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nigerians with rectal bleeding

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* must be 45-years of age or older
* has rectal bleeding lasting at least one week
* has had a complete colonoscopy performed

Exclusion Criteria:

* 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

Primary outcomes:
measure: To determine colonoscopy polyp and cancer detection rate
timeFrame: 2 years
Secondary outcomes:
measure: To detect colorectal cancer early using symptoms based assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Ile Ife
country: Nigeria
facility: Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals
state: Osun
Study officials:
References:
citation: 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.