Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06889844

Enrollment

250

Registered

2025-03-21

Start date

2023-04-17

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

Colorectal Cancer

Brief summary

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.

Interventions

DIAGNOSTIC_TESTblood sampling

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
False Positive Rate	36 month	To estimate the false positive rate of the blood-based test in the main population of the study

Countries

Spain

Contacts

Primary ContactMarta Jimenez

mjimenez@amadix.com+34637899149

Outcome results

None listed

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