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

Study description: the study is a clinical trial aimed at assessing the validity of a point-of-care tool developed for colorectal cancer screening using urine metabolites.

Objectives:

Primary Objective:

In the pilot phase, investigators will field test the POC device in Nigeria on 75 patients who are high-risk for CRC and then validate the urine metabolite signature using a large cohort of 645 patients at high risk for CRC and polyps. This will allow us to determine the sensitivity and specificity of this device and these signatures for CRC and polyps.

Endpoints: the endpoint will be the calculation of the validity (sensitivity and specificity) of the tool. Positive and negative predictive values will also be calculated.

Study population:

Patients > 40 years of age with LGI bleeding for more than one-week OR

• Patients who are high risk due to a family history of CRC (first-degree relative)
• 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)
• Patients with a diagnosis of stage I-III CRC who have no evidence of disease Both males and females will be involved in the study

I. The study will evaluate the validity and acceptability of the POC biosensor device in Nigeria.

Description of sites/facilities enrolling participants: the study will be conducted at Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) which hosts the head office of African Research Group for Oncology (ARGO). The study will also run concurrently at other ARGO collaborating sites. All the ARGO collaborating sites are tertiary health care facilities with experienced personnel to oversee the study. The pilot study will, however, take place in OAUTHC alone.

Study duration:

The accrual time for the validation study is 2.5 years. Participant Duration: the study will require initial one-time contact. Those that are positive during the screening with the POC biosensor device will be booked for colonoscopy. Hence, for participants with positive results to complete the study may require 2 weeks on average.

Study Overview

• Status: Suspended
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Diagnostic test: Urine PolypDx machine Versus Colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 645
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Osun
    • Ife, Osun, Nigeria, 220005
      • Obafemi Awolowo University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients > 40 years of age with LGI bleeding for more than one week OR
• Patients who are high risk due to a family history of CRC (first-degree relative)
• 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)
• Patients with a diagnosis of stage I-III CRC who have no evidence of disease

Exclusion Criteria:

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 that the anesthesiologist or surgeon determines is a contraindication for colonoscopy in their facility.
• 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

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients low gastrointestinal tract bleeding; Patients presenting in the surgical outpatients or emergency department with low gastrointestinal tract bleeding	Diagnostic test: Urine PolypDx machine Versus Colonoscopy; Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer; Colonoscopy, which is the gold standard for colorectal cancer diagnosis/screening will be performed on all the participants positive for metabolites signifying CRC on Urine PolypDx machine in all the groups
Active Comparator: Participants who are high risk due to a family history of CRC; First degree relatives of patients diagnosed with colorectal cancer	Diagnostic test: Urine PolypDx machine Versus Colonoscopy; Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer; Colonoscopy, which is the gold standard for colorectal cancer diagnosis/screening will be performed on all the participants positive for metabolites signifying CRC on Urine PolypDx machine in all the groups
Active Comparator: Patients with a diagnosis of stage I-III CRC who have no evidence of disease; Patients previously diagnosed of stage I-III CRC and managed in the hospital but are now having no evidence of disease	Diagnostic test: Urine PolypDx machine Versus Colonoscopy; Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer; Colonoscopy, which is the gold standard for colorectal cancer diagnosis/screening will be performed on all the participants positive for metabolites signifying CRC on Urine PolypDx machine in all the groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Urine PolypDx device in detecting colorectal cancer	Results from the urine assay will be compared with the histology report of the tissue taken during colonoscopy, the gold standard for colorectal cancer diagnosis. Sensitivity, specificity, positive predictive value, and negative predictive values will be calculated	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity Urine PolypDx device in detecting colorectal cancer (CRC)	Proportion of those urine PolyDx device detects to have CRC that actually have CRC	One month
Specificity Urine PolypDx device in detecting colorectal cancer (CRC)	Proportion of those urine PolyDx device detects not to have CRC that actually do not have CRC	One month
Positive Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)	Proportion of those who test positive with urine PolyDx device that actually do have CRC that actually have CRC	One month
Negative Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)	Proportion of those who test negative with urine PolyDx device that actually do not have CRC that actually have CRC	One month

Collaborators and Investigators

• Sponsor: Obafemi Awolowo University Teaching Hospital
• Collaborators: Memorial Sloan Kettering Cancer Center; National Institutes of Health (NIH); University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 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: NHREC/01/01/2007-18/10/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) will be shared
• IPD Sharing Time Frame: The data will be available after publication of the data
• IPD Sharing Access Criteria: Data will be made accessible upon reasonable request directed to the principal investigator of this study by any researcher in related fields
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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