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

NCT03032874 | Completed

• 1 other identifier: ERC/2013/02/07
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Polyps; Colonoscopy; Rectal bleeding; Nigeria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To detect colorectal cancer early using symptoms based assessment

  2 years

Study Arms (2)

Training set

All the patients with rectal bleeding who had colonoscopy performed at Obafemi Awolowo University Teaching Hospitals Complex

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

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

They all had screening colonoscopy

Training set; Validation set

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nigerians with rectal bleeding

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals

Ile-Ife, Osun State, 220005, Nigeria

Location

Related Publications (1)

• 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.

  PMID: 29645077 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colonic polyps and colorectal cancer specimen

MeSH Terms

Conditions

Colorectal Neoplasms; Polyps; Gastrointestinal Hemorrhage

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon/Senior Lecturer

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 26, 2017
• Study Start: January 1, 2014
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

NG (1)