Clinical trial Recruiting at 4 sites Observational Ages 18 and up

Evaluating a blood test for colorectal cancer diagnosis

Official title: 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

Run by Advanced Marker Discovery S.l. · NCT06889844 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorAdvanced Marker Discovery S.l.
Industry-sponsored
Drugs / interventionschemotherapy
Locations5 sites (Málaga, Andalusia and 4 other locations)
StatusRecruiting
StartedApril 17, 2023
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedOctober 1, 2025
Trial IDNCT06889844 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.