Actively Recruiting
Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics in Stage III Non Small Cell Lung Cancer as part of the GUIDE.MRD Project
Led by University Medical Center Groningen · Updated on 2025-03-30
248
Participants Needed
6
Research Sites
243 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
Researchers are investigating new diagnostic methods to improve personalized treatment for patients with stage III non-small cell lung cancer (NSCLC). Current methods for deciding post-treatment care after surgery or chemoradiotherapy are not optimal, leading to overtreatment or undertreatment. This study is part of the GUIDE.MRD project, which aims to validate circulating tumor DNA (ctDNA) tests to better detect residual cancer and guide treatment decisions in NSCLC patients. The study focuses on evaluating multiple ctDNA diagnostic tests using clinical samples collected at specific time points: baseline, after neoadjuvant treatment, post-surgery or chemoradiotherapy, post-adjuvant therapy, and at disease progression or study end. Participants include those receiving chemoradiotherapy followed by immunotherapy, neoadjuvant therapy followed by surgery or radiotherapy, or surgery followed by immunotherapy. Blood samples will be analyzed retrospectively to compare ctDNA test performance without influencing treatment decisions. Participants will provide plasma samples at these key time points for analysis. Researchers will measure the sensitivity, specificity, and predictive values of the ctDNA tests and assess outcomes including three-year recurrence-free survival and the timing between ctDNA detection and clinical relapse. The study also evaluates how ctDNA results relate to responses to neoadjuvant and adjuvant therapies. Participation involves sample collection and clinical monitoring over multiple years, with data helping to improve future treatment selection for stage III NSCLC.
CONDITIONS
Brief Title
Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non small cell lung cancer (NSCLC) stage III (cT1-4, cN0-3, M0)
- Age 18 years or older
- Scheduled for treatment with curative intent including surgery and/or radiotherapy
- Ability to understand and sign written informed consent
- Underwent baseline contrast-enhanced CT of thorax and abdomen or PET/CT, brain MRI or CT, and pulmonary function tests (FEV1 and DLCO/KCO at minimum)
- Availability of sufficient tumor material (≥50ng tumor DNA, FFPE) from baseline or after surgery
You will not qualify if you...
- Presence of distant metastases
- Having synchronous NSCLC and non-NSCLC cancer (except non-melanoma skin cancer)
- Having other cancers except NSCLC or non-melanoma skin cancer, or cancers treated curatively with over 5 years follow-up without recurrence
- Unlikely to comply with study protocol or unable to attend follow-up visits
- No available tissue sample or tumor content in tissue sample less than 20%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From baseline through post-treatment and up to disease progression
Participants provide clinical samples at multiple key time points to assess circulating tumor DNA (ctDNA) diagnostics.
Samples collected at 4 to 5 landmark time points including baseline, post-neoadjuvant treatment, post-surgery or chemoradiotherapy, post-adjuvant therapy, and at end of study or disease progression
Duration - Up to 3 years after end of recruitment
Participants are monitored over time to assess recurrence-free survival and clinical outcomes related to ctDNA findings.
Follow-up visits for up to 3 years for recurrence and clinical assessment
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
E
Ed Schuuring, PhD
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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