Validation of a Molecular Signature for Early Detection of Colorectal Cancer

Not Applicable

Completed

• Conditions: Colorectal Cancer Screening; Advanced Adenomas (AA)

• Registration Number: NCT06738511
• Lead Sponsor: ADVANCED MARKER DISCOVERY S.L.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-28
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3421

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Demonstrate the diagnosis capacity of molecular signature in plasma samples	48 months

Secondary Outcome Measures

Name	Time	Method
Demonstrate superiority of molecular signature in plasma samples compared with FIT	48 months

Trial Locations

Locations (2)

MVZ für Gastroenterolgie am Bayerischen Platz; 🇩🇪 Berlin, Germany

Narodowy Instytut Onkologii w Warszawie Zakład Profilaktyki Nowotworów; 🇵🇱 Warszawa, Poland