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

Launched by ADVANCED MARKER DISCOVERY S.L. · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a test called PreveCol® to see if it can effectively help detect colorectal cancer and advanced precancerous conditions in people who have already received a positive result from a standard stool test (FOBT). The goal is to determine how well the PreveCol test works, how safe it is, and what preferences participants have regarding screening methods. The trial is looking for participants aged 50 to 69 years who are at average risk for colorectal cancer, meaning they have no personal or family history of certain conditions that would put them at higher risk.

If you decide to participate, you will provide a blood sample before undergoing a routine colonoscopy and fill out two questionnaires about your experience and preferences. This study is currently recruiting participants, and it’s important that you understand the details of the trial before agreeing to join. Overall, this trial aims to improve early detection of colon cancer and help shape future screening programs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants ages from 50 to 69 years (both included) at the time of informed consent signed.
• • Participants should sign an informed consent. They must understand the nature, significance, implications, and risks of the clinical study before signing the informed consent form.
• • Participants with a positive result of FIT/FOBT analysis referred to the gastroenterology department who are eligible to undertake colonoscopy as a regular procedure of the colorectal cancer screening programme.
• • Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or over with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).
• Exclusion Criteria:
• • Participants who have developed any another type of cancer in the 5 years prior to their participation in the study.
• • Participants who have previously received chemotherapy or radiotherapy (5 years).
• • Participants previously or currently diagnosed with Familiar Adenomatous Polyposis or Lynch Syndrome or Inflammatory Bowel Disease.
• • Inadequate intestinal preparation for colonoscopy with BBPS score ≤1 in any colon section, excluding diagnostic of CRC.
• • Participants who have undergone polypectomy in the previous 5 years.
• • Hemolysis of blood sample or absence of blood sample.
• • Participants who are arrested at judicial or official request
• • Participants who are in a dependent personal or non-medical relationship with the Sponsor or the investigator.