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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ctDNA

Treatment groups

248 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University Medical Center Groningen

Lead sponsor

LungenClinic Grosshansdorf

Collaborator

Centre Hospitalier Universitaire de Nice

Collaborator