Non-invasive urine and stool tests for early colorectal cancer diagnosis
Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile
This study is testing if special urine and stool tests can help find colorectal cancer early in patients who have already had a positive blood test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Reus, Tarragona and 1 other locations) |
| Trial ID | NCT06452745 on ClinicalTrials.gov |
What this trial studies
This project aims to identify specific metabolites in urine and stool samples that can differentiate between patients with colorectal cancer or polyps and healthy individuals. By utilizing metabolomics techniques, the study seeks to develop a cost-effective and non-invasive screening method for early diagnosis of colorectal cancer. The research focuses on patients who have tested positive in a fecal occult blood test (FOBT) and are referred for colonoscopy. The goal is to improve early detection rates and ultimately reduce mortality associated with colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates include individuals with a positive FOBT result who are being referred for a colonoscopy.
Not a fit: Patients with other primary cancers diagnosed in the last five years or severe kidney or liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of colorectal cancer, improving patient outcomes.
How similar studies have performed: While there have been studies exploring metabolomics in cancer detection, this specific approach focusing on non-invasive urine and stool analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a positive FOBT test result from the Colorectal Cancer Early Detection Program and referred for a colonoscopy. Exclusion Criteria: * Patients diagnosed with another primary neoplasm in the last 5 years, with the exception of carcinoma in situ of the cervix or non-melanoma skin cancer. * Patients with severe kidney disease stage IV (creatinine clearance \< 30 ml/min). * Patients with severe active liver disease (hepatitis, cirrhosis). * Refusal to sign informed consent.
Where this trial is running
Reus, Tarragona and 1 other locations
- Hospital Universitari Sant Joan de Reus — Reus, Tarragona, Spain (Recruiting)
- Hospital Universitari Joan XXIII — Tarragona, Tarragona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.