Actively Recruiting

Age: 18Years +
All Genders
ID06111807

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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