Evaluating PreveCol for Early Detection of Colorectal Cancer
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
This study is testing a new blood test called PreveCol to see if it can help find colorectal cancer and advanced polyps in people aged 50-69 who have already had a positive stool test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4538 (estimated) |
| Ages | 50 Years to 69 Years |
| Sex | All |
| Sponsor | Advanced Marker Discovery S.l. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Lisbon, Lisbon District and 1 other locations) |
| Trial ID | NCT06703632 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic individuals aged 50-69 with a positive FIT/FOBT result and no significant personal or family history of colorectal cancer.
Not a fit: Patients with a history of other cancers, previous chemotherapy or radiotherapy, or those with significant colorectal cancer risk factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early detection of colorectal cancer, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using liquid biopsy methods for cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lisbon, Lisbon District and 1 other locations
- Hospital de Santa Maria — Lisbon, Lisbon District, Portugal (Not_yet_recruiting)
- Hospital Universitario Ramon y Cajal — Madrid, Madrid, Spain (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.