Evaluating PreveCol for Early Detection of Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to assess the efficiency of the PreveCol® test as a second-line method for detecting colorectal cancer and advanced adenomas in individuals aged 50-69 with a prior positive FOBT result. Participants will provide blood samples and complete questionnaires before undergoing a screening colonoscopy. The study will evaluate the efficacy, efficiency, impact, and safety of the PreveCol test, as well as participant preferences for screening methods. The findings could enhance colorectal cancer screening protocols.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Ramon y Cajal
  Madrid, Madrid, Spain Recruiting
• Hospital de Santa Maria
  Lisbon, Lisbon District, Portugal Not yet recruiting

Study contacts

• Principal investigator: Agustin Albillos, MD — Hospital Universitario Ramon y Cajal
• Study coordinator: Marta Jimenez, PhD
• Email: mjimenez@amadix.com
• Phone: +34 637899149

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.