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Evaluation of a New Blood-based Test to Detect Colorectal Cancer and Its Precursors

NCT04980443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 809

Last updated 2023-02-01

No results posted yet for this study

Summary

The CELTiC panel is a potential blood-based test for detecting colorectal cancer (CRC) and precursors of CRC. This can be useful for CRC screening, since this requires tests that detect cancer in an early stage to maximize the chances of successful treatment.

CELTiC combines four markers that can be detected in blood. These markers are composed of so-called messenger RNA (mRNA) and can be viewed as the instructions of our genes to the cell to make certain proteins. Cancer is the result of mutation in these genes. Thus, the mRNA in cancer patients is, depending on the type of mRNA, often abnormal. In earlier studies, the developers of CELTiC found four mRNA's that are different in patients with CRC compared to healthy individuals. However, CELTiC has not yet been extensively studied in individuals for whom the test is intended: a population undergoing CRC screening.

The current study aims to fill this gap. We will assess the ability of CELTiC to detect CRC and precursors of CRC in a population of individuals between 50 and 75 years old in the Netherlands and Italy. This population has already been preselected by having a positive fecal immunochemical test (FIT), a test that is frequently used in CRC screening. This population will undergo a colonoscopy, a procedure where a doctor enters the large bowel through the anus using a flexible camara to assess whether the patient has cancer. Prior to this colonoscopy, we will collect blood samples from the individuals to assess their CELTiC score. After the colonoscopy and the blood analysis, we can assess whether the test adequately detects CRC and precursors of CRC in this population.

Conditions

  • Colorectal Cancer
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Colorectal Polyp
  • Colorectal Adenoma

Interventions

DIAGNOSTIC_TEST

CELTiC test

The CELTiC test is a blood-based test consisting of four mRNA markers and the risk factor age.

Sponsors & Collaborators

  • Bergman Clinics

    collaborator OTHER

  • University of Bologna

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2022-10-01
Completion
2022-11-01

Countries

  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT04980443 on ClinicalTrials.gov