NCT06703632Recruiting
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Source: ClinicalTrials.gov · Last updated 27 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 4538 (estimated)
- First submitted
- 19 Nov 2024
- Start date
- 14 Jan 2025
- Primary completion date
- Nov 2025
- Lead sponsor
- ADVANCED MARKER DISCOVERY S.L.
- Diseases
- Colorectal cancer
- NCT number
- NCT06703632
What you commit to
- Study type: Interventional
- Planned participants: 4538
- From 14 Jan 2025 to the primary completion date, Nov 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Participants who have undergone polypectomy in the previous 5 years.
Other
- Inadequate intestinal preparation for colonoscopy with BBPS score ≤1 in any colon section, excluding diagnostic of CRC.
- 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.
Who the study is looking for
- 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).
Age in the registry: 50 years to 69 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital De Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.