Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer (ColoDix)

September 29, 2025 updated by: ADVANCED MARKER DISCOVERY S.L.

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 is a prospective, multicenter, case-control study. The aim is to develop an optimized algorithm by combining the levels of molecular markers in plasma together with risk factors for developing colorectal cancer and clinical data of patients diagnosed with CRC or AA and healthy individuals.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Aragon
      • Zaragoza, Aragon, Spain
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
    • Basque Country
      • Bilbao, Basque Country, Spain
        • Recruiting
        • Hospital Universitario de Cruces
      • Donostia / San Sebastian, Basque Country, Spain
        • Completed
        • Policlinica Gipuzkoa Hospital
    • Cantabria
      • Santander, Cantabria, Spain
        • Terminated
        • Hospital Universitario Marques de Valdecilla
    • Castille and León
      • Salamanca, Castille and León, Spain
        • Recruiting
        • Hospital Universitario de Salamanca
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Completed
        • Hospital Sant Rafael
      • Barcelona, Catalonia, Spain
        • Completed
        • Hospital Universitario Vall d' Hebron
    • Madrid
      • Madrid, Madrid, Spain
        • Active, not recruiting
        • Md Anderson Cancer Centre
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain
        • Recruiting
        • Hospital Centro Médico de Asturias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study involves the recruitment of 510 patients as part of a case-control study. Patients who are going to undergo colonoscopy or who are going to undergo surgery for resection of a CRC already diagnosed will be included. They can be symptomatic or asymptomatic, ambulatory, hospitalized or consecutive patients in the Endoscopy Unit.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy
Individual with no findings or findings not related to neoplasia on colonoscopy
Advanced Adenoma
Patient diagnosed with advanced adenoma by colonoscopy and confirmed by histology result
Colorectal Cancer
Patient diagnosed with colorectal cancer by colonoscopy and confirmed by histology result

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Validation
Time Frame: 36 months
To clinically validate the diagnostic capability of the algorithm for early detection of CRC and AA that combines molecular markers and risk factors
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADVANCED MARKER DISCOVERY S.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMD-CCR-2022-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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