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
This trial does not accept healthy volunteersQualifiers
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 population
Stage III NSCLC with curative intent treatment
Trial design
Cohort
Prospective
Treatments tested in this trial
ctDNA
Diagnostic testctDNA will be tested retrospectively, no treatment decisions will be made prospectively
Treatment groups
Trial outcomes
Primary outcomes
Collection of clinical plasma samples at relevant time points
For head-to-head performance assessment and benchmarking of ctDNA diagnostics
Secondary outcomes
The 3-year recurrence-free survival
recurrence free survival by RECIST1.1
Lead time between ctDNA detection and clinical recurrence
recurrence by RECIST1.1
Prognostic value of ctDNA analysis at relevant time points
for complete pathological response, disease progression, event free and overall survival
Sponsors and contacts
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University Medical Center Groningen
Lead sponsor
LungenClinic Grosshansdorf
Collaborator
Centre Hospitalier Universitaire de Nice
Collaborator