Validation of a Molecular Signature for Early Detection of Colorectal Cancer

NCT06738511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3421

Last updated 2024-12-17

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Screening
  • Advanced Adenomas (AA)

Interventions

DIAGNOSTIC_TEST

blood sampling

Molecular signature using plasma sample

OTHER

stool sampling

Stool sampling (by the participant)

OTHER

colonoscopy

Colonoscopy will be performed in the course of a screening programme

Sponsors & Collaborators

  • European Union H2020 SME Instrument

    collaborator UNKNOWN
  • ADVANCED MARKER DISCOVERY S.L.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2021-09-01
Completion
2021-09-01

Countries

  • Germany
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06738511 on ClinicalTrials.gov