Actively Recruiting
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Led by ADVANCED MARKER DISCOVERY S.L. · Updated on 2025-02-27
4538
Participants Needed
2
Research Sites
45 weeks
Total Duration
On this page
Sponsors
A
ADVANCED MARKER DISCOVERY S.L.
Lead Sponsor
H
Hospital Universitario Ramon y Cajal
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 69 years at time of consent
- Signed informed consent after understanding the study
- Positive result from FIT/FOBT test and referred for colonoscopy
- Asymptomatic with average risk for colorectal cancer (no personal or family history of colorectal cancer, adenoma, or inflammatory bowel disease)
You will not qualify if you...
- Diagnosis of any other cancer within 5 years prior to study
- Previous chemotherapy or radiotherapy within 5 years
- Diagnosis of Familial Adenomatous Polyposis, Lynch Syndrome, or Inflammatory Bowel Disease
- Inadequate bowel preparation for colonoscopy (BBPS score ≤1 in any colon section, except colorectal cancer diagnosis)
- Polypectomy performed in the previous 5 years
- Hemolysis or absence of blood sample
- Being detained by judicial or official request
- Dependent personal or non-medical relationship with the sponsor or investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
Not Yet Recruiting
2
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain
Actively Recruiting
Research Team
M
Marta Jimenez, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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