Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

The objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is

Does the blood test have a low false positive rate in the main study population?

Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.

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Key information

Conditions

Colorectal Cancer 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

Hospitales HM de Malaga, Málaga, Andalusia, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Blood sampling

Diagnostic Test

Patients will donate a blood sample for molecular analysis of molecular biomarkers in plasma, which being the only procedure in the study.

Primary outcomes

False Positive Rate

Time frame: 36 month

To estimate the false positive rate of the blood-based test in the main population of the study

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Sponsors and collaborators

Lead sponsor

ADVANCED MARKER DISCOVERY S.L.

Industry

Registry information

Official study 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

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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