Evaluating a blood test for colorectal cancer diagnosis
Observational Cross-reactivity Study to Evaluate the Specificity of a Blood Test for Colorectal Cancer Diagnosis Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools
This study is testing a blood test to see if it can accurately tell if people do not have colorectal cancer, helping to reduce incorrect positive results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Marker Discovery S.l. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Málaga, Andalusia and 4 other locations) |
| Trial ID | NCT06889844 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the false positive rate of a blood test that utilizes molecular biomarkers and risk factors for colorectal cancer diagnosis. A total of 250 patients with various cancers and gastrointestinal diseases will participate by donating blood samples as part of their routine medical care. The study will focus on understanding whether the blood test can accurately identify patients without colorectal cancer, thereby minimizing false positives in the diagnosis process.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with a single type of cancer or gastrointestinal disease, excluding colorectal cancer.
Not a fit: Patients with a history of colorectal cancer or related conditions, as well as those who have undergone certain cancer treatments, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate colorectal cancer diagnostics, reducing unnecessary anxiety and invasive procedures for patients.
How similar studies have performed: While there have been studies on blood tests for cancer diagnosis, this specific approach focusing on false positive rates in colorectal cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 18 years of age at the time of blood sample collection. * Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form. * Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease. Exclusion Criteria: * Patients who have received previous chemotherapy or radiotherapy. * In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor. * Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome. * Patients without appropriate staging or diagnosis. * Patients with hemolyzed plasma.
Where this trial is running
Málaga, Andalusia and 4 other locations
- Hospitales HM de Malaga — Málaga, Andalusia, Spain (Recruiting)
- Hospital Centro Médico Asturias — Oviedo, Cantabria, Spain (Recruiting)
- Hospital Universitario de Ourense — Ourense, Galicia, Spain (Recruiting)
- Hospital Universitario HM Sanchinarro — Madrid, Madrid, Spain (Recruiting)
- MD Anderson Cancer Centre — Madrid, Madrid, Spain (Active_not_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.