Evaluating ctDNA diagnostics for Stage III lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate and benchmark the performance of circulating tumor DNA (ctDNA) diagnostics in patients with Stage III non-small cell lung cancer (NSCLC). By analyzing blood samples from patients undergoing curative treatment, the study seeks to determine which ctDNA tests are most effective at various clinical stages, such as post-surgery and during treatment surveillance. The GUIDE.MRD consortium, comprising experts from various fields, will collect and analyze these samples to establish reliable standards for ctDNA testing and improve personalized treatment strategies for lung cancer patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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%

Where it's running

• Centre Hospitalier Universitaire de Nice
  Nice, Nice, France Recruiting
• Isala
  Zwolle, Overijssel, Netherlands Recruiting
• University Medical Center Groningen, Departments of Pulmonology and Pathology
  Groningen, Provincie Groningen, Netherlands Recruiting
• Ommelander Ziekenhuis Groningen
  Scheemda, Provincie Groningen, Netherlands Recruiting
• Antoine Lacassagne Center
  Nice, Nice, France Not yet recruiting
• Department of thoracic oncology- LungenClinic Großhansdorf
  Großhansdorf, Grosshansdorf, Germany Not yet recruiting

Study contacts

• Study coordinator: T.Jeroen N Hiltermann, MD, PhD
• Email: t.j.n.hiltermann@umcg.nl
• Phone: 503644936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.