Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

NCT06889844 · tracked via the Priya Life Science Spain tracker

Sponsor

ADVANCED MARKER DISCOVERY S.L

Phase

Observational

Started

2023-04-17

Last updated

2025-10-01

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

blood sampling

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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.

Primary outcome measure(s)

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

Trial sites (5)

Facility	City	Region	Status
Hospitales HM de Malaga	Málaga	Andalusia	Recruiting
Hospital Centro Médico Asturias	Oviedo	Cantabria	Recruiting
Hospital Universitario de Ourense	Ourense	Galicia	Recruiting
Hospital Universitario HM Sanchinarro	Madrid	Madrid	Recruiting
MD Anderson Cancer Centre	Madrid	Madrid	Active Not Recruiting

More ADVANCED MARKER DISCOVERY S.L. trials in Spain

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

Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection Recruiting

Exploring Participant Preference for Screening Methods and Experience Into Colorectal Cancer Screening Programme Recruiting

Other trials for the same condition

Single cEll pRofiling PErsistaNce To ImmuNothErapy Recruiting

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting

Early Diagnosis of Colorectal Cancer Based on a Non-invasive Metabolomics Profile Recruiting

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab Active, not recruiting

Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06889844 on ClinicalTrials.gov ↗ ← All trials in Spain