RecruitingNCT06111807

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

GUIding Multi-moDal thErapies Against MRD by LiquidBiopsies in Non Small Cell Lung Cancer- GUIDE.MRD-03-NSCLC

Sponsor

University Medical Center Groningen

Enrollment

248 participants

Start Date

Nov 10, 2023

Study Type

OBSERVATIONAL

Conditions

Lung Cancer Stage III

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria5

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%