Validation of a Molecular Signature for Early Detection of Colorectal Cancer

ADVANCED MARKER DISCOVERY S.L.

Status

Completed

Conditions

Advanced Adenomas (AA)

Colorectal Cancer Screening

Treatments

Other: stool sampling

Diagnostic Test: blood sampling

Other: colonoscopy

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06738511

AMD-EUC-2016

Details and patient eligibility

About

The goal of this Multicentre and international prospective study is to validate a molecular signature using plasma samples in average-risk population for colorectal cancer who undergo colonoscopy in a screening setting.

The main question it aims to answer is:

Does molecular signature in plasma sample have higher diagnostic accuracy than FIT for early detection of colorectal cancer? Participants who already have a colonoscopy as part of their regular medical care for colorectal cancer screening will provide a stool sample and a plasma sample.

Enrollment

3,421 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants between the ages of 50 and 75 (both included) at the time of informed consent signed. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
Participants referred to the gastroenterology service who are going to undertake colonoscopy as a regular procedure for screening setting.
Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or older with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).

Exclusion criteria

Participants between the ages of 50 and 75 (both included) at the time of Informed consent signature. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
Participants who have been diagnosed with CRC. The diagnosis must be subsequently confirmed by biopsy or surgery and pathological anatomy analysis during the study.