NCT04980443: CELTiC

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

Completed NA Last updated 1 February 2023

What this trial tests

NA trial testing CELTiC test in Colorectal Cancer in 809 participants. Completed in 1 November 2022.

Timeline

3 August 2021

Primary endpoint
1 October 2022

1 November 2022

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	809
Start date	3 August 2021
Primary completion	1 October 2022
Estimated completion	1 November 2022
Sites	4 locations across Italy, Netherlands

Drugs / interventions tested

• CELTiC test

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
• Colorectal Carcinoma — all drugs for Colorectal Carcinoma →
• Colorectal Polyp — all drugs for Colorectal Polyp →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

Adults 50 to 75, any sex, with Colorectal Cancer or Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Application and development of noninvasive biomarkers for colorectal cancer screening: a systematic review.
   Song D, Wang F, Ju Y, He Q, et al · · 2023 · cited 17× · PMID 36974713 · DOI 10.1097/js9.0000000000000260
2. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes.
   Kortlever TL, Ferlizza E, Lauriola M, Borrelli F, et al · · 2025 · PMID 40207404 · DOI 10.1111/apt.70141