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

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Control in Low Resource Countries: Results From a Prospective Cohort Study of Patients at High-risk for Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032874
• Other study ID #: ERC/2013/02/07
• Status: Completed
• Phase: N/A
• First received: January 25, 2017
• Last updated: January 27, 2017
• Start date: January 1, 2014
• Est. completion date: July 30, 2016

Study information

• Verified date: January 2017
• Source: Obafemi Awolowo University Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2016
• Est. primary completion date: July 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Colonoscopy
They all had screening colonoscopy

Locations

Country	Name	City	State
Nigeria	Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals	Ile Ife	Osun

Sponsors (4)

Lead Sponsor	Collaborator
Obafemi Awolowo University Teaching Hospital	Memorial Sloan Kettering Cancer Center, New York, USA, University College Hospital, Nigeria, University of Ilorin Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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