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

NCT ID: NCT03032874

Last Updated: 2017-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2016-07-30

Brief Summary

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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

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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

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training set

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

Colonoscopy

Intervention Type PROCEDURE

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

Colonoscopy

Intervention Type PROCEDURE

They all had screening colonoscopy

Interventions

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Colonoscopy

They all had screening colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center, New York, USA

UNKNOWN

Sponsor Role collaborator

University College Hospital, Nigeria

UNKNOWN

Sponsor Role collaborator

University of Ilorin Teaching Hospital

OTHER

Sponsor Role collaborator

Obafemi Awolowo University Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olusegun Alatise

Consultant Surgeon/Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals

Ile-Ife, Osun State, Nigeria

Site Status

Countries

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Nigeria

References

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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.

Reference Type DERIVED
PMID: 29645077 (View on PubMed)

Other Identifiers

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ERC/2013/02/07

Identifier Type: -

Identifier Source: org_study_id

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