Colorectal Cancer, CRC, Precancerous Polyp, Rectal Bleeding
Conditions
Keywords
Colorectal Cancer, Precancerous Polyp, Rectal Bleeding, Symptoms of Colorectal Cancer, CRC, Memorial Sloan Kettering Cancer Center, 26-187
Brief summary
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_TEST3-metabolite biosensor
3-metabolite biosensor will identify participants with colorectal cancer (CRC) and precancerous polyps
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of 3-metabolite biosensor | up to 1 year | 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). |
Countries
Ghana, South Africa, Tanzania, United States
Contacts
CONTACTPeter Kingham, MD
CONTACTAlexia Iasonos, PhD
PRINCIPAL_INVESTIGATORPeter Kingham, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed