Status:
RECRUITING
Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
LungenClinic Grosshansdorf
Centre Hospitalier Universitaire de Nice
Conditions:
Lung Cancer Stage III
Eligibility:
All Genders
18+ years
Brief 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 metho...
Detailed Description
GUIDE.MRD-03-NSCLC is a part of WP3 of the overarching GUIDE.MRD project. Each study chair has a local clinical trial protocol where patients are recruited. After the end of recruitment, samples will ...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
November 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT06111807
Start Date
November 10 2023
End Date
July 31 2030
Last Update
March 30 2025
Active Locations (6)
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1
Centre Hospitalier Universitaire de Nice
Nice, Nice, France, 06000
2
Antoine Lacassagne Center
Nice, Nice, France, 06189
3
Department of thoracic oncology- LungenClinic Großhansdorf
Großhansdorf, Grosshansdorf, Germany, 22927
4
Isala
Zwolle, Overijssel, Netherlands, 8025AB