Smart Measurement of Circulating Tumor DNA

NCT06989814 | Recruiting

• 2 other identifiers: NL87476.078.2414976
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to develop a blood-test which can detect colorectal cancer in early stages. Participants will be asked to take an extra blood test, which will be analyzed further in the lab.

Conditions

Colorectal Neoplasms; Colorectal Neoplasms Malignant; Colorectal Neoplasms, Hereditary Nonpolyposis; Hereditary Nonpolyposis Colon Cancer

Keywords

Liquid Biopsy; Colorectal cancer; Early detection; Prevention; Surveillance; Screening

Outcome Measures

Primary Outcomes (2)

• Estimated ctDNA fractions in blood

  ctDNA presence will be measured against a (presently not specified) threshold, creating a divide between 'detectable' and 'non-detectable'.

  Measurement at baseline

• Tumor pathology

  Tumor pathology will be revised to later compare with estimated ctDNA presence.

  Measurement at baseline

Study Arms (1)

Lynch-carriers with a (colorectal) tumor

EXPERIMENTAL

People with a newly diagnosed Lynch-associated tumor will be asked to undergo an extra blood test.

Diagnostic Test: Blood Product

Interventions

Blood Product DIAGNOSTIC_TEST

An (extra) blood test will be done on participants. This will be analyzed for circulating tumor DNA (ctDNA) via a multi-omics approach.

Also known as: Blood test, Blood draw, Liquid biopsy

Lynch-carriers with a (colorectal) tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (suspect) Lynch Syndrome carriers who:
• Have proven Lynch Syndrome (MMR-gene or EPCAM mutation), or have a proven microsatellite instability high (MSI-H)tumor;
• Have granted informed consent to participate in this study.

You may not qualify if:

• (suspect) Lynch Syndrome carriers who:
• Are unwilling to undergo extra blood sampling;
• Are under the age of 18;
• Are not able to read or understand Dutch language or are mentally not capable.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Cancer Society: collaborator
• Leiden University Medical Center: collaborator

Study Sites (2)

Leiden University Medical Center

Leiden, South Holland, 2333ZG, Netherlands

NOT YET RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Related Publications (4)

• Mouliere F, Chandrananda D, Piskorz AM, Moore EK, Morris J, Ahlborn LB, Mair R, Goranova T, Marass F, Heider K, Wan JCM, Supernat A, Hudecova I, Gounaris I, Ros S, Jimenez-Linan M, Garcia-Corbacho J, Patel K, Ostrup O, Murphy S, Eldridge MD, Gale D, Stewart GD, Burge J, Cooper WN, van der Heijden MS, Massie CE, Watts C, Corrie P, Pacey S, Brindle KM, Baird RD, Mau-Sorensen M, Parkinson CA, Smith CG, Brenton JD, Rosenfeld N. Enhanced detection of circulating tumor DNA by fragment size analysis. Sci Transl Med. 2018 Nov 7;10(466):eaat4921. doi: 10.1126/scitranslmed.aat4921.

  PMID: 30404863 BACKGROUND

• Deger T, Boers RG, de Weerd V, Angus L, van der Put MMJ, Boers JB, Azmani Z, van IJcken WFJ, Grunhagen DJ, van Dessel LF, Lolkema MPJK, Verhoef C, Sleijfer S, Martens JWM, Gribnau J, Wilting SM. High-throughput and affordable genome-wide methylation profiling of circulating cell-free DNA by methylated DNA sequencing (MeD-seq) of LpnPI digested fragments. Clin Epigenetics. 2021 Oct 20;13(1):196. doi: 10.1186/s13148-021-01177-4.

  PMID: 34670587 BACKGROUND

• Schrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2.

  PMID: 37805216 BACKGROUND

• Eikenboom EL, Wilting SM, Deger T, Srebniak MI, Van Veghel-Plandsoen M, Boers RG, Boers JB, van IJcken WFJ, Gribnau JH, Atmodimedjo P, Dubbink HJ, Martens JWM, Spaander MCW, Wagner A. Liquid Biopsies for Colorectal Cancer and Advanced Adenoma Screening and Surveillance: What to Measure? Cancers (Basel). 2023 Sep 17;15(18):4607. doi: 10.3390/cancers15184607.

  PMID: 37760576 RESULT

Related Links

• Information (in Dutch) on the Dutch Cancer Society website

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Hematologic Tests; Blood Specimen Collection; Liquid Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative; Biopsy; Cytodiagnosis; Cytological Techniques

Study Officials

• Anja Wagner, Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotte van Leeuwen, BSc

CONTACT

+31646245198; l.vanleeuwen@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: Case-control study.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 25, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)