Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC

NCT06111807 · tracked via the Priya Life Science Germany tracker

Sponsor

University Medical Center Groningen

Phase

Observational

Started

2023-11-10

Last updated

2025-03-30

Condition(s) studied

Lung Cancer Stage III

Investigational drug(s) / intervention(s)

ctDNA

ctDNA: ctDNA will be tested retrospectively, no treatment decisions will be made prospectively

Study summary

Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for non small cell lung cancer (NSCLC), the methods used to decide who gets additional post radical (surgery or definite chemo-radiotherapy) treatment are suboptimal. Some patients get too much treatment, while others do not get enough.

There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.

The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.

GUIDE.MRD-03-NSCLC is a part of the GUIDE.MRD project.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * NSCLC, clinical tumor stage III (cT1-4, cN0-3, M0). * Patient 18 years or older. * Scheduled for curative intent treatment (surgery and/or radiotherapy). * Patient able to understand and sign written informed consent. * Baseline contrast enhanced CT thorax abdomen (or PET/CT), MRI (or CT) brain, Pulmonary function tests (at least FEV1 and DLCO/KCO). * Ability to obtain sufficient tumor material (≥50ng tumor DNA, FFPE ). Either at baseline or after surgery. Exclusion Criteria: * Verified distant metastases. * With synchronous NSCLC cancer and non-NSCLC cancer (except skin cancer other than melanoma). * With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence). * Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study. * No tissue sample available for the project, or tumor content in the tissue sample is \<20%

Primary outcome measure(s)

Collection of clinical plasma samples at relevant time points — 8 months after end of recruitment
For head-to-head performance assessment and benchmarking of ctDNA diagnostics

Trial sites (6)

Facility	City	Region	Status
Centre Hospitalier Universitaire de Nice	Nice	Nice	Recruiting
Antoine Lacassagne Center	Nice	Nice	Not Yet Recruiting
Department of thoracic oncology- LungenClinic Großhansdorf	Großhansdorf	Grosshansdorf	Not Yet Recruiting
Isala	Zwolle	Overijssel	Recruiting
University Medical Center Groningen, Departments of Pulmonology and Pathology	Groningen	Provincie Groningen	Recruiting
Ommelander Ziekenhuis Groningen	Scheemda	Provincie Groningen	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06111807 on ClinicalTrials.gov ↗ ← All trials in Germany