Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection (MS-Prevecol)

February 25, 2025 updated by: ADVANCED MARKER DISCOVERY S.L.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multicentre, international, no-competitive, prospective, transversal, and low-risk interventional study coming from average risk participants (50-69 years old) from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy.

Study Type

Interventional

Enrollment (Estimated)

4538

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Not yet recruiting
        • Hospital de Santa Maria
        • Contact:
          • Ana Rita, MD
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Agustin Albillos, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PreveCol test after a FOBT positive result
Average-risk participants from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy
Other: Survey using a questionnaire.
Preference questionnaire for colorectal cancer screening methods
Diagnostic test: blood sampling
PreveCol test based on blood sampling
Other Names:
  • PreveCol
Other: Survey using a questionnaire.
PREMs for colorectal cancer screening programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value
Time Frame: 12 months
Value of efficiency through the clinical performance (sensitivity, specificity, positive predictive value and negative predictive value) of PreveCol® after FOBT positive result for detecting neoplastic lesions.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of cancer
Time Frame: 12 months
Value of PreveCol's efficiency in second line for detecting cancer
12 months
Diagnostic performance of lesions
Time Frame: 12 months
Value of PreveCol's efficiency in second line for advanced lesions
12 months
Value of questionnaires into screening programme
Time Frame: 12 months
The percentage of number of answers from each preference questions and PREMs
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 12 months
Measure the percentage of adverse events and complications directly/indirectly related to interventions of study.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADVANCED MARKER DISCOVERY S.L.

Collaborators

Hospital Universitario Ramon y Cajal
Hospital de Santa Maria, Lisbon

Investigators

  • Principal Investigator: Agustin Albillos, MD, Hospital Universitario Ramon y Cajal
  • Principal Investigator: Ana Rita, MD, Hospital de Santa Maria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 19, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Actual)

November 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMD-CCR-2024-02
  • 2024-NDMH-5101_240046 (Other Grant/Funding Number: EIT-Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Carcinoma

Clinical Trials on Survey using a questionnaire.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe