NCT06111807Recruiting
Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC
GUIding Multi-moDal thErapies Against MRD by LiquidBiopsies in Non Small Cell Lung Cancer- GUIDE.MRD-03-NSCLC
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 248 (estimated)
- First submitted
- 26 Oct 2023
- Start date
- 10 Nov 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Lung cancer
- NCT number
- NCT06111807
What you commit to
- Study type: Observational
- Planned participants: 248
- From 10 Nov 2023 to the primary completion date, 1 Dec 2025
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- Verified distant metastases.
- 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%
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of thoracic oncology- LungenClinic Großhansdorf Coordinator of this site? Confirm its status | Großhansdorf | Germany | Not yet recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Antoine Lacassagne Center Coordinator of this site? Confirm its status | Nice | France | Not yet recruiting |
| University Medical Center Groningen, Departments of Pulmonology and Pathology Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Ommelander Ziekenhuis Groningen Coordinator of this site? Confirm its status | Scheemda | Netherlands | Recruiting |
| Isala Coordinator of this site? Confirm its status | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.