NCT04980443

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
809

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 3, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

July 19, 2021

Last Update Submit

January 31, 2023

Conditions

Colorectal CancerColorectal NeoplasmsColorectal CarcinomaColorectal PolypColorectal Adenoma

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of CELTiC

    The sensitivity of the CELTiC test for detecting advanced neoplasia

    AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.

Secondary Outcomes (3)

  • Specificity of CELTiC

    AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.

  • Positive Predictive Value of CELTiC

    AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.

  • C-statistic of CELTiC

    AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.

Other Outcomes (1)

  • Association between CELTiC test score and FIT concentration

    AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy. FIT will be collected from the national CRC screening databases.

Study Arms (1)

FIT positive individuals

EXPERIMENTAL

FIT-positive individuals of whom we will collect blood samples and who will undergo a colonoscopy after blood sampling.

Diagnostic Test: CELTiC test

Interventions

CELTiC testDIAGNOSTIC_TEST

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

FIT positive individuals

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FIT concentration of 20 ug Hb/g or higher (Italy) or 47 ug Hb/g or higher (Netherlands) in the national CRC screening program as reason for referral.
  • Age between 55 and 75 years (Netherlands) or 50 and 69 years (Italy)

You may not qualify if:

  • No signed informed consent
  • History or current treatment for colorectal cancer
  • History of inflammatory bowel disease
  • History of other condition for which colonoscopy surveillance is planned within the next 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Università di Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

Amsterdam UMC, locatie Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Bergman Clinics

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Erasmus University Medical Center

Rotterdam, South Holland, 3015CN, Netherlands

Location

Related Publications (9)

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND

  • Arnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27.

    PMID: 26818619BACKGROUND

  • Schreuders EH, Ruco A, Rabeneck L, Schoen RE, Sung JJ, Young GP, Kuipers EJ. Colorectal cancer screening: a global overview of existing programmes. Gut. 2015 Oct;64(10):1637-49. doi: 10.1136/gutjnl-2014-309086. Epub 2015 Jun 3.

    PMID: 26041752BACKGROUND

  • Ran T, Cheng CY, Misselwitz B, Brenner H, Ubels J, Schlander M. Cost-Effectiveness of Colorectal Cancer Screening Strategies-A Systematic Review. Clin Gastroenterol Hepatol. 2019 Sep;17(10):1969-1981.e15. doi: 10.1016/j.cgh.2019.01.014. Epub 2019 Jan 16.

    PMID: 30659991BACKGROUND

  • Rodia MT, Solmi R, Pasini F, Nardi E, Mattei G, Ugolini G, Ricciardiello L, Strippoli P, Miglio R, Lauriola M. LGALS4, CEACAM6, TSPAN8, and COL1A2: Blood Markers for Colorectal Cancer-Validation in a Cohort of Subjects With Positive Fecal Immunochemical Test Result. Clin Colorectal Cancer. 2018 Jun;17(2):e217-e228. doi: 10.1016/j.clcc.2017.12.002. Epub 2017 Dec 12.

    PMID: 29352642BACKGROUND

  • Ferlizza E, Solmi R, Miglio R, Nardi E, Mattei G, Sgarzi M, Lauriola M. Colorectal cancer screening: Assessment of CEACAM6, LGALS4, TSPAN8 and COL1A2 as blood markers in faecal immunochemical test negative subjects. J Adv Res. 2020 Mar 3;24:99-107. doi: 10.1016/j.jare.2020.03.001. eCollection 2020 Jul.

    PMID: 32257432BACKGROUND

  • Senore C, Basu P, Anttila A, Ponti A, Tomatis M, Vale DB, Ronco G, Soerjomataram I, Primic-Zakelj M, Riggi E, Dillner J, Elfstrom MK, Lonnberg S, Sankaranarayanan R, Segnan N. Performance of colorectal cancer screening in the European Union Member States: data from the second European screening report. Gut. 2019 Jul;68(7):1232-1244. doi: 10.1136/gutjnl-2018-317293. Epub 2018 Dec 10.

    PMID: 30530530BACKGROUND

  • Rodia MT, Ugolini G, Mattei G, Montroni I, Zattoni D, Ghignone F, Veronese G, Marisi G, Lauriola M, Strippoli P, Solmi R. Systematic large-scale meta-analysis identifies a panel of two mRNAs as blood biomarkers for colorectal cancer detection. Oncotarget. 2016 May 24;7(21):30295-306. doi: 10.18632/oncotarget.8108.

    PMID: 26993598BACKGROUND

  • Kortlever TL, Ferlizza E, Lauriola M, Borrelli F, Porro A, Spaander MCW, Bossuyt PM, Ricciardiello L, Dekker E. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes. Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10.

    PMID: 40207404DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Endoscopy staff will be blinded to the result of the CELTiC test. Additionally, laboratory staff that assesses the CELTiC test will be blinded to the result of the colonoscopy.
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: We will cross-sectionally assess the CELTiC test in a group of FIT-positive individuals.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor doctor

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 28, 2021

Study Start

August 3, 2021

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)NL(3)