Community Based Screening for Colorectal Cancer in an Underserved High Risk Population in Nigeria

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Colonoscopy

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Nigeria
  • Osun
    • Ile Ife, Osun, Nigeria, 220005
      • Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Nigerians with rectal bleeding

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training set; All the patients with rectal bleeding who had colonoscopy performed at Obafemi Awolowo University Teaching Hospitals Complex	Procedure: Colonoscopy; They all had screening colonoscopy
Validation set; All the patients with rectal bleeding who had colonoscopy performed at University College Hospital, Ibadan and University of Ilorin Teaching Hospital	Procedure: Colonoscopy; They all had screening colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Collaborators and Investigators

• Sponsor: Obafemi Awolowo University Teaching Hospital
• Collaborators: University of Ilorin Teaching Hospital; Memorial Sloan Kettering Cancer Center, New York, USA; University College Hospital, Nigeria

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): July 30, 2016
• Study Completion (Actual): July 30, 2016

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Colorectal cancer; Colonoscopy; Nigeria; Polyps; Rectal bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ERC/2013/02/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Each request will be review on their merit by the team and approval of the Ethic and Research Committee that approve the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No