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Development and Validation of a 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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06889883
Acronym
ColoDix
Enrollment
510
Registered
2025-03-21
Start date
2023-06-06
Completion date
2025-12-31
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Adenomas (AA), Colorectal Carcinoma

Brief summary

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.

Interventions

None listed

Sponsors

ADVANCED MARKER DISCOVERY S.L.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Validation36 monthsTo clinically validate the diagnostic capability of the algorithm for early detection of CRC and AA that combines molecular markers and risk factors

Countries

Spain

Contacts

Primary ContactMarta Jimenez
mjimenez@amadix.com+34637899149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026