Actively Recruiting
Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC
Led by University Medical Center Groningen · Updated on 2025-03-30
248
Participants Needed
6
Research Sites
350 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
L
LungenClinic Grosshansdorf
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Verified distant metastases
- Presence of synchronous NSCLC and non-NSCLC cancer (except skin cancer other than melanoma)
- Other cancers except NSCLC or skin cancer (non-melanoma), or cancers treated curatively with over 5 years follow-up without recurrence
- Unlikely to comply with the protocol or unable to return for subsequent visits
- No tissue sample available for the project, or tumor content in the tissue sample is <20%
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Centre Hospitalier Universitaire de Nice
Nice, Nice, France, 06000
Actively Recruiting
2
Antoine Lacassagne Center
Nice, Nice, France, 06189
Not Yet Recruiting
3
Department of thoracic oncology- LungenClinic Großhansdorf
Großhansdorf, Grosshansdorf, Germany, 22927
Not Yet Recruiting
4
Isala
Zwolle, Overijssel, Netherlands, 8025AB
Actively Recruiting
5
University Medical Center Groningen, Departments of Pulmonology and Pathology
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
6
Ommelander Ziekenhuis Groningen
Scheemda, Provincie Groningen, Netherlands, 9679BJ
Actively Recruiting
Research Team
T
T.Jeroen N Hiltermann, MD, PhD
CONTACT
E
Ed Schuuring, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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