GUIding Multi-moDal thErapies Against MRD by LiquidBiopsies in Non Small Cell Lung Cancer- GUIDE.MRD-03-NSCLC

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Antoine Lacassagne Center
NOT_YET_RECRUITING
Nice
Centre Hospitalier Universitaire de Nice
RECRUITING
Nice
Germany
Department of thoracic oncology- LungenClinic Großhansdorf
NOT_YET_RECRUITING
Großhansdorf
Netherlands
University Medical Center Groningen, Departments of Pulmonology and Pathology
RECRUITING
Groningen
Ommelander Ziekenhuis Groningen
RECRUITING
Scheemda
Isala
RECRUITING
Zwolle
Contact Information
Primary
T.Jeroen N Hiltermann, MD, PhD
t.j.n.hiltermann@umcg.nl
503644936
Backup
Ed Schuuring, PhD
e.schuuring@umcg.nl
503619623
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 248
Treatments
Chemo-radiotherapy
Stage 3 NSCLC eligible for chemoradiotherapy
Neoadjuvant and surgery
Stage 3 NSCLC eligible for neoadjuvant chemo-immunotherapy followed by surgery
Surgery and adjuvant immunotherapy
Stage 3 NSCLC eligible for surgery followed by immunotherapy
Sponsors
Collaborators: LungenClinic Grosshansdorf, Centre Hospitalier Universitaire de Nice
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov