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

Summary

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

• Screening for Colon Cancer
• Blood Samples
• Survey and Questionnaire
• Colorectal Carcinoma
• Colon Adenocarcinoma
• Precancerous Lesion of Colon

Interventions

DIAGNOSTIC_TEST

blood sampling

PreveCol test based on blood sampling

OTHER

Survey using a questionnaire.

Preference questionnaire for colorectal cancer screening methods

OTHER

Survey using a questionnaire.

PREMs for colorectal cancer screening programme

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital de Santa Maria, Lisbon

  collaborator UNKNOWN

• ADVANCED MARKER DISCOVERY S.L.

  lead INDUSTRY

Principal Investigators

• Agustin Albillos, MD · Hospital Universitario Ramon y Cajal

• Ana Rita, MD · Hospital de Santa Maria

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-14

Primary Completion

2025-11-30

Completion

2025-12-31

Countries

• Portugal
• Spain

Study Locations