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Trial Title:
Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries
NCT ID:
NCT05679960
Condition:
Colorectal Cancer Screening
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Suspended
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Urine PolypDx machine Versus Colonoscopy
Description:
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
Arm group label:
Participants who are high risk due to a family history of CRC
Arm group label:
Patients low gastrointestinal tract bleeding
Arm group label:
Patients with a diagnosis of stage I-III CRC who have no evidence of disease
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Obafemi Awolowo University Teaching Hospital
Address:
City:
Ife
Zip:
220005
Country:
Nigeria
Start date:
August 15, 2022
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Obafemi Awolowo University Teaching Hospital
Agency class:
Other
Collaborator:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
University of Alberta
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Obafemi Awolowo University Teaching Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679960
