Blood test for early diagnosis of colorectal cancer
Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools
This study is testing a new blood test to see if it can help find colorectal cancer and advanced polyps earlier in people who are at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Marker Discovery S.l. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Zaragoza, Aragon and 8 other locations) |
| Trial ID | NCT06889883 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a blood test that combines molecular markers in plasma with risk factors and clinical data to improve early diagnosis of colorectal cancer and advanced adenomas. It involves a multicenter, case-control design where patients undergoing colonoscopy or surgical resection will be compared to healthy individuals. The goal is to create an optimized algorithm that enhances the accuracy of early detection.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are scheduled for colonoscopy or surgical resection due to suspected colorectal cancer.
Not a fit: Patients with a history of cancer in the past 5 years or those with certain benign conditions like non-advanced adenomas will not benefit from this study.
Why it matters
Potential benefit: If successful, this blood test could lead to earlier diagnosis of colorectal cancer, potentially improving patient outcomes and survival rates.
How similar studies have performed: While there have been studies exploring blood tests for cancer detection, this specific approach combining molecular markers and clinical data is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over the age of 18 who are able to understand the participant information and sign the informed consent. * Patients who are going to undergo colonoscopy or surgical resection for tumor (CRC). Exclusion Criteria: * Patients who had developed any type of cancer in the 5 years prior to their participation in this study. * Patients who have received previous chemotherapy or radiotherapy. * Patients diagnosed with non-advanced adenomas, serrated polyps, Familial Adenomatous Polyposis or Lynch Syndrome. * Patients with inadequate bowel preparation for colonoscopy. * Patients who have undergone colonoscopy/polipectomy in the previous 5 years. * Patients with hemolyzed plasma.
Where this trial is running
Zaragoza, Aragon and 8 other locations
- Hospital Clinico Universitario Lozano Blesa — Zaragoza, Aragon, Spain (Recruiting)
- Hospital Universitario de Cruces — Bilbao, Basque Country, Spain (Recruiting)
- Policlinica Gipuzkoa Hospital — Donostia / San Sebastian, Basque Country, Spain (Completed)
- Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain (Terminated)
- Hospital Universitario de Salamanca — Salamanca, Castille and León, Spain (Recruiting)
- Hospital Sant Rafael — Barcelona, Catalonia, Spain (Completed)
- Hospital Universitario Vall d' Hebron — Barcelona, Catalonia, Spain (Completed)
- MD Anderson Cancer Centre — Madrid, Madrid, Spain (Active_not_recruiting)
- Hospital Centro Médico de Asturias — Oviedo, Principality of Asturias, Spain (Recruiting)
Study contacts
- Study coordinator: Marta Jimenez
- Email: mjimenez@amadix.com
- Phone: +34637899149
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.