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Completed

NCT Number: NCT03032874

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

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

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals

Ile-Ife, Osun State, 220005, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy

Procedure

They all had screening colonoscopy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Obafemi Awolowo University Teaching Hospital

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center
  • University College Hospital, Nigeria
  • University of Ilorin Teaching Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2017
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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