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

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.

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Key information

Conditions

Colorectal Carcinoma Advanced Adenomas (AA) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinico Universitario Lozano Blesa, Zaragoza, Aragon, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

ADVANCED MARKER DISCOVERY S.L.

Industry

Registry information

Official study title

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

Acronym: ColoDix

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Mar 21, 2025
Registry last updated: Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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