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OpenTrials
Completed

NCT Number: NCT06738511

Validation of a Molecular Signature for Early Detection of Colorectal Cancer

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.

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Key information

Conditions

Colorectal Cancer Screening Advanced Adenomas (AA) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MVZ für Gastroenterolgie am Bayerischen Platz, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Diagnostic Test

Molecular signature using plasma sample

Stool sampling

Other

Stool sampling (by the participant)

colonoscopy

Other

Colonoscopy will be performed in the course of a screening programme

Primary outcomes

  1. Demonstrate the diagnosis capacity of molecular signature in plasma samples

    Time frame: 48 months

Secondary outcomes

  1. Demonstrate superiority of molecular signature in plasma samples compared with FIT

    Time frame: 48 months

Other outcomes

  1. Performance of molecular signature in plasma samples (Diagnostic capability) in cases of false positive or false negatives obtained in FIT

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

ADVANCED MARKER DISCOVERY S.L.

Industry

Collaborators

  • European Union

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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