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

NCT05679960 | Suspended DMC

• 1 other identifier: NHREC/01/01/2007-18/10/2021
• Study Type: interventional
• Target: 645
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensitivity Urine PolypDx device in detecting colorectal cancer (CRC)

  One month

• Specificity Urine PolypDx device in detecting colorectal cancer (CRC)

  One month

• Positive Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)

  One month

• Negative Predictive Value Urine PolypDx device in detecting colorectal cancer (CRC)

  One month

Study Arms (3)

Patients low gastrointestinal tract bleeding

ACTIVE COMPARATOR

Patients presenting in the surgical outpatients or emergency department with low gastrointestinal tract bleeding

Diagnostic Test: Urine PolypDx machine Versus Colonoscopy

Participants who are high risk due to a family history of CRC

ACTIVE COMPARATOR

First degree relatives of patients diagnosed with colorectal cancer

Diagnostic Test: Urine PolypDx machine Versus Colonoscopy

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

ACTIVE COMPARATOR

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

Interventions

Urine PolypDx machine Versus Colonoscopy DIAGNOSTIC_TEST

1. Urine samples of the participants in each group will be analyzed to check for preidentified metabolites that signified colorectal cancer 2. 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

Participants who are high risk due to a family history of CRC; Patients low gastrointestinal tract bleeding; Patients with a diagnosis of stage I-III CRC who have no evidence of disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Obafemi Awolowo University Teaching Hospital

Ile-Ife, Osun State, 220005, Nigeria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Consultant Surgeon

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: January 11, 2023
• Study Start: August 15, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available after publication of the data
• Access Criteria: Data will be made accessible upon reasonable request directed to the principal investigator of this study by any researcher in related fields

Locations

NG (1)