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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 69
Healthy Volunteers: t
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• 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).

Locations
Other Locations
Portugal
Hospital de Santa Maria
NOT_YET_RECRUITING
Lisbon
Spain
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Contact Information
Primary
Marta Jimenez, PhD
mjimenez@amadix.com
+34 637899149
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2025-12
Participants
Target number of participants: 4538
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: ADVANCED MARKER DISCOVERY S.L.
Collaborators: Hospital de Santa Maria, Lisbon, Hospital Universitario Ramon y Cajal

This content was sourced from clinicaltrials.gov