Validation of a Molecular Signature for Early Detection of Colorectal Cancer

ADVANCED MARKER DISCOVERY S.L.2 sites in 2 countries3,421 target enrollmentMay 28, 2018

ConditionsColorectal Cancer Screening Advanced Adenomas (AA)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer Screening
Sponsor: ADVANCED MARKER DISCOVERY S.L.
Enrollment: 3421
Locations: 2
Primary Endpoint: Demonstrate the diagnosis capacity of molecular signature in plasma samples
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this Multicentre and international prospective study is to validate a molecular signature using plasma samples in average-risk population for colorectal cancer who undergo colonoscopy in a screening setting.

The main question it aims to answer is:

Does molecular signature in plasma sample have higher diagnostic accuracy than FIT for early detection of colorectal cancer? Participants who already have a colonoscopy as part of their regular medical care for colorectal cancer screening will provide a stool sample and a plasma sample.

Registry

clinicaltrials.gov

Start Date

May 28, 2018

End Date

September 1, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ADVANCED MARKER DISCOVERY S.L.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants between the ages of 50 and 75 (both included) at the time of informed consent signed. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
•Participants referred to the gastroenterology service who are going to undertake colonoscopy as a regular procedure for screening setting.
•Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or older with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).

Exclusion Criteria

•Participants between the ages of 50 and 75 (both included) at the time of Informed consent signature. They must understand the nature, significance, implications and risks of the clinical trial and must sign the informed consent form.
•Participants who have been diagnosed with CRC. The diagnosis must be subsequently confirmed by biopsy or surgery and pathological anatomy analysis during the study.