Smart Measurement of Circulating Tumor DNA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have proven Lynch Syndrome (MMR-gene or EPCAM mutation), or have a proven microsatellite instability high (MSI-H)tumor;

Are at least 18 years old; Have been diagnosed with any form of cancer at the time of inclusion, but have had no treatment yet;

Have granted informed consent to participate in this study.

Disqualifiers

Are unwilling to undergo extra blood sampling;

Are under the age of 18;

Have no newly diagnosed tumors at time of inclusion;

Have been treated for their tumor at time of inclusion;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Lynch-carriers with a (colorectal) tumorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Estimated ctDNA fractions in blood

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

Time frame
Measurement at baseline
2

Tumor pathology

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

Time frame
Measurement at baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Dutch Cancer Society

Collaborator

Leiden University Medical Center

Collaborator