Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries

Point of Care, Real-time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low and Middle Income Countries

This is a-two phase study. Phase 1 will adapt a 3-metabolite biosensor that identifies patients with colorectal cancer (CRC) and precancerous polyps to Nigerian patients. Phase 2 will pilot test and evaluate the point-of-care (POC) biosensor device in Nigeria.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: Biosensor Point of Care Device

Detailed Description

In Phase 1, urine will be collected from 450 Nigerian patients (150 with CRC, 150 with polyps, and 150 patients with no colon premalignant or malignant pathology. These samples will be used to refine a handheld biosensor. This handheld biosensor is intended to be a cost-effective POC diagnostic test highly sensitive for CRC in Nigerian patients.

In Phase 2, the biosensor device will be piloted in Nigeria with 75 patients that are high-risk for CRC.. After the pilot, POC test in real-time analysis on urine from 645 patients who are in one of three groups: 1.> 40 years of age with rectal bleeding; 2.a family history of CRC; 3. have a diagnosis of CRC. All patients will receive a colonoscopy. Beliefs and barriers related to urine testing for CRC will be investigated. Study will be completed within 5 years.

• Study Type: Observational
• Enrollment (Actual): 926

Contacts and Locations

• Study Contact: Name: Olusegun Alatise, MD; Phone Number: 2348033859387; Email: segunalatishe@gmail.com
• Study Contact Backup: Name: T. Peter Kingham, MD; Phone Number: 212-639-5260; Email: KinghamT@mskcc.org

Study Locations

• Nigeria
  • Kwara State
    • Ilorin, Kwara State, Nigeria
      • Endoscopy Unit, University of Ilorin Teaching Hospital
  • Ondo State
    • Owo, Ondo State, Nigeria
      • Federal Medical Center
  • Osun
    • Ile Ife, Osun, Nigeria, 220005
      • Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals
  • Osun State
    • Ibadan, Osun State, Nigeria
      • Endoscopy Unit, University College Hospital
    • Osogbo, Osun State, Nigeria
      • Ladoke Akintola University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients in Phase 1 has a pathologic diagnosis of colon cancer (either by colonoscopy or resection specimens), or colonoscopy demonstrating adenomatous polyps or no colon premalignant or malignant pathology.

Patients in Phase 2 are > 40 years of age with LGI bleeding, or at high-risk due to family history, or with a history of CRC

Description

Inclusion Criteria:

• Patients > 40 years of age with LGI bleeding OR

• Patients who are high risk due to family history of CRC

  o Must be at most 10 years younger than when relative presented with CRC (for example, a patient with a relative diagnosed at age 40 with CRC will be eligible after age 30) OR

• Patients with a diagnosis of stage I-III CRC who have no evidence of disease

Exclusion Criteria:

• Patients who are unable to provide written informed consent;
• Previous diagnosis, treatment, or surgery for any cancer other than CRC
• Age younger than 40 years with no family history of CRC
• Any significant medical comorbidities
• Inability to provide a urine sample no fewer than 3 days before colonoscopy
• Inability to fully complete the patient satisfaction survey tool
• Diagnosis of or suspected inflammatory bowel disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase 1 Cohort 1; CRC (n = 150)
Phase 1 Cohort 2; Precancerous polyps (n = 150)
Phase 1 Cohort 3; Normal controls (n = 150)
Phase 2 Field Test; 75 patients who are high risk for CRC as described in the eligibility	Diagnostic test: Biosensor Point of Care Device; This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.
Phase 2 Validation Study Cohort 1; Family history of CRC (n = 330)	Diagnostic test: Biosensor Point of Care Device; This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.
Phase 2 Validation Study Cohort 2; LGI bleeding (n = 240)	Diagnostic test: Biosensor Point of Care Device; This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.
Phase 2 Validation Study Cohort 3; Patients with history of CRC (n = 75)	Diagnostic test: Biosensor Point of Care Device; This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of a point of care device to diagnose colorectal cancer and polyps	We have designed a urine-based point of care diagnostic test to risk-stratify patients at high-risk for colorectal cancer. that will have 50% specificity and 80% sensitivity among Nigerian targeted population.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that are willing to consider continued colorectal cancer surveillance with a urine point of care test.	The barriers and attitudes of patients towards a point of care urine test will be used to predict how many patients are willing to use this methodology.	3 years
Cost per patient of point of care urine test for diagnosing patients with colorectal cancer and polyps.	The cost per patient will be determined using a cost effectiveness model already developed for the urine screening test in high-income countries.	3 years

Collaborators and Investigators

• Sponsor: Obafemi Awolowo University Teaching Hospital
• Collaborators: Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2017
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ERC/2017/02/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will follow the NIH/NCI approved guidelines

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No