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NCT Number: NCT06703632

Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection

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.

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Key information

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Santa Maria, Lisbon, Lisbon District, Portugal

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Diagnostic Test

PreveCol test based on blood sampling

Other names: PreveCol

Survey using a questionnaire.

Other

Preference questionnaire for colorectal cancer screening methods

Primary outcomes

  1. 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.

Secondary outcomes

  1. Diagnostic performance of cancer

    Time frame: 12 months

    Value of PreveCol's efficiency in second line for detecting cancer

  2. Diagnostic performance of lesions

    Time frame: 12 months

    Value of PreveCol's efficiency in second line for advanced lesions

  3. Value of questionnaires into screening programme

    Time frame: 12 months

    The percentage of number of answers from each preference questions and PREMs

Other outcomes

  1. Safety

    Time frame: 12 months

    Measure the percentage of adverse events and complications directly/indirectly related to interventions of study.

Study contacts

Contact information is provided by the study sponsor or research team.

Marta Jimenez, PhD

CONTACT

[email protected]

+34 637899149

Sponsors and collaborators

Lead sponsor

ADVANCED MARKER DISCOVERY S.L.

Industry

Collaborators

  • Hospital Universitario Ramon y Cajal
  • Hospital de Santa Maria, Lisbon

Registry information

Acronym: MS-Prevecol

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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