Recruiting NCT07649057
A Study of a Urine Test to Detect Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3-metabolite biosensor.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Precancerous Polyp, Rectal Bleeding, CRC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Ghana, South Africa, Tanzania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Determining the Success of a Urine Metabolite Point-of-care Colorectal Cancer Early Diagnosis Test in Africa
Overview
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.
Interventions
- Diagnostic test 3-metabolite biosensor
3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps
Primary outcome measures
- Sensitivity of 3-metabolite biosensor [Time frame: up to 1 year]
Eligibility criteria
Inclusion criteria
- Patient presents with one of the following:
- 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-
- Patients with colonoscopy demonstrating adenomatous polyps -OR-
- Patients with colonoscopy demonstrating no colon or premalignant or malignant pathology
- Age ≥ 18
- Willingness to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
Ghana · 1 center
- Korle Bu Teaching Hospital (Data Collection Only) — Accra
South Africa · 1 center
- Wits Donald Gordon Medical Centre (Data Collection Only) — Johannesburg
Tanzania · 1 center
- Kilimanjaro Christian Medical Centre (Data Collection Only) — Moshi
Identifiers
NCT: NCT07649057 · 26-187