RecruitingNot ApplicableNCT06703632

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

Sponsor

ADVANCED MARKER DISCOVERY S.L.

Enrollment

4,538 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Carcinoma Colon Adenocarcinoma Screening for Colon Cancer Survey and Questionnaire Blood Samples Precancerous Lesion of Colon

Summary

The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are: * Values of efficacy, efficiency, impact and safety of PreveCol. * Values of preferences of participants for screening methods. * Values of PREMs into screening programme. Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.

Eligibility

Min Age: 50 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a blood-based test (PreveCol) can accurately identify people who need a colonoscopy after a positive stool test, potentially reducing unnecessary procedures. **You may be eligible if...** - You are between 50 and 69 years old - You had a positive FIT or FOBT stool test and have been referred for a colonoscopy - You have no symptoms and are at average risk for colorectal cancer (no personal or family history of adenomas, CRC, or bowel disease) - You have signed the informed consent form **You may NOT be eligible if...** - You have been diagnosed with any other cancer in the past 5 years - You have previously received chemotherapy or radiation (in the past 5 years) - You have familial adenomatous polyposis, Lynch syndrome, or inflammatory bowel disease - You have had a polyp removed in the past 5 years - Your blood sample was not usable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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