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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032874
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 30, 2017
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center, New York, USA
University College Hospital, Nigeria
University of Ilorin Teaching Hospital
Information provided by (Responsible Party):
Olusegun Alatise, Obafemi Awolowo University Teaching Hospital

Tracking Information
First Submitted Date January 25, 2017
First Posted Date January 26, 2017
Last Update Posted Date January 30, 2017
Actual Study Start Date January 1, 2014
Actual Primary Completion Date July 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2017)
To determine colonoscopy polyp and cancer detection rate [ Time Frame: 2 years ]
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.
Original Primary Outcome Measures
 (submitted: January 25, 2017)
Polyp and cancer detection rate [ Time Frame: 2 years ]
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.
Change History
Current Secondary Outcome Measures
 (submitted: January 27, 2017)
To detect colorectal cancer early using symptoms based assessment [ Time Frame: 2 years ]
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
Original Secondary Outcome Measures
 (submitted: January 25, 2017)
Early detection of colorectal cancer [ Time Frame: 2 years ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Colonic polyps and colorectal cancer specimen
Sampling Method Non-Probability Sample
Study Population Nigerians with rectal bleeding
Condition Colorectal Cancer
Intervention Procedure: Colonoscopy
They all had screening colonoscopy
Study Groups/Cohorts
  • Training set
    All the patients with rectal bleeding who had colonoscopy performed at Obafemi Awolowo University Teaching Hospitals Complex
    Intervention: 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
    Intervention: Procedure: Colonoscopy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 25, 2017)
100
Original Actual Enrollment Same as current
Actual Study Completion Date July 30, 2016
Actual Primary Completion Date July 30, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number NCT03032874
Other Study ID Numbers ERC/2013/02/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
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
Responsible Party Olusegun Alatise, Obafemi Awolowo University Teaching Hospital
Study Sponsor Obafemi Awolowo University Teaching Hospital
Collaborators
  • Memorial Sloan Kettering Cancer Center, New York, USA
  • University College Hospital, Nigeria
  • University of Ilorin Teaching Hospital
Investigators Not Provided
PRS Account Obafemi Awolowo University Teaching Hospital
Verification Date January 2017