A Study of a Urine Test to Detect Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to find out whether a urine test can detect colorectal cancer (CRC) and precancerous polyps in participants living in Ghana, Tanzania, and South Africa.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with symptoms of CRC (such as rectal bleeding for a week) -OR-
Patients who present for a screening colonoscopy -OR-
Has received one of the following within 3 weeks of the planned urine collection
Patients with a pathologic diagnosis of CRC either by colonoscopy or resection specimens -OR-
Disqualifiers
None
Trial population
Data and samples will be collected from 3 sites in Africa: Korle Bu Teaching Hospital/University of Ghana Medical School in Ghana; Kilimanjaro Christian Medical Centre in Tanzania and Wits Donald Gordon Medical Centre, Wits Donald Gordon Medical Research Institute in South Africa. Consent will occur at these sites.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
3-metabolite biosensor
Diagnostic test3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: Participants with Colorectal Cancer/CRC1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of 3-metabolite biosensor
The study will validate a 3-metabolite biosensor that identifies participants with colorectal cancer (CRC) and precancerous polyps in Ghana, Tanzania and South Africa. The primary aim is to show that the sensitivity and specificity in other regions are as good as the Nigerian estimates (i.e. 90% and 80% respectively).
Time frame
up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov