Trial Title:
Implementation of Up-front ctDNA Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - LM² Study
NCT ID:
NCT06105177
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
lungmarker2 study
lung cancer
liquid biopsy
ctDNA
CTCs
tumormarkers
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Despite scientific evidence, use of liquid biopsy (LB) in diagnosis and monitoring of
lung cancer (LC) is limited since it requires major changes in diagnostic and care
pathways. Analyzing tumor markers (TMs), circulating tumor cells (CTCs) and circulating
tumor DNA (ctDNA) in blood (LB) can inform about the nature of the tumor, the most
appropriate therapy, therapy response and resistance.
Lungmarker2 is a multicenter, prospective, implementation and diagnostic cohort study.
This study aims to implement up-front ctDNA analysis ('plasma first approach') into
routine diagnostic work-up of all advanced stage LC patients in the Southeast of the
Netherlands (the participating hospitals in the OncoZON region). Thereby, additional
information about the molecular make-up of the tumor becomes available, the number of
tissue Next-Generation Sequencing (NGS) analyses will decrease and time to therapeutic
decision making is shortened. Next, using ctDNA, TM and other information,
multi-parametric decision support models are built and validated that may support
diagnosis, predict the outcome of the next imaging procedure and progression-free
survival during follow-up. The final goal is to develop a super-resolution microscopy
test that can detect PD-L1 expression on CTCs.
Detailed description:
RATIONALE: Despite scientific evidence, use of liquid biopsy (LB) in diagnosis and
monitoring of lung cancer (LC) is limited since it requires major changes in diagnostic
and care pathways. Analyzing tumor markers (TMs), circulating tumor cells (CTCs) and
circulating tumor DNA (ctDNA) in blood (LB) can inform about the nature of the tumor, the
most appropriate therapy, therapy response and resistance.
OBJECTIVE: To implement up-front ctDNA analysis ('plasma first approach') into routine
diagnostic work-up of all advanced stage LC patients in the Southeast of the Netherlands
(the participating hospitals in the OncoZON region) and to thereby validate that
significantly more information about the molecular make-up of the tumor becomes available
by introduction of up-front ctDNA. To establish that the number of tissue NGS analyses
decreases and time to therapeutic decision making is shortened. To build and to validate,
using ctDNA, TM and other information, multiparametric decision support models that may
support diagnosis, predict the outcome of the next imaging procedure and survival during
follow up. The final goal is to develop a super-resolution microscopy test that can
detect PD-L1 expression on CTCs.
STUDY DESIGN: Multicenter, prospective, implementation and diagnostic cohort study.
STUDY POPULATION: 800 patients suspected of having lung cancer.
MAIN STUDY PARAMETERS/ENDPOINTS: ctDNA analysis, as additional source of genetic
information, has been integrated into the diagnostic workup of LC patients and the
medical benefits thereof are quantified, e.g. a significant higher percentage of patients
with a driver mutation is identified by introduction of the plasma first approach.
Multiparametric decision support algorithms based on imaging, TM and ctDNA analyses that
identify small-cell LC (SCLC) and non-small-cell LC (NSCLC) have been developed and
validated. Multiparametric decision support models have been developed that enable
patient-specific timing of imaging procedures and predict survival during follow-up of LC
patients. A super-resolution microscopy test for PD-L1 is developed and correlation with
tumor tissue PD-L1 expression has been established.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND
GROUP RELATEDNESS: At diagnosis, an extra 10 mL of blood are drawn during a routine
venipuncture. Patients with advanced stage LC (stage IIIb/c or IV) undergo an extra
venipuncture (40 mL).The longest follow up period for a patient is 36 months with a
maximum of 20 blood draws. The volume per draw ranges from 10-40 mL. The risks of a
venipuncture are negligible and the burden minimal. Those patients for whom a targetable
mutation is found by ctDNA analysis benefit from the advantages of targeted therapy, i.e.
better survival and less side effects of the treatment.
Criteria for eligibility:
Study pop:
800 individuals, >18 years of age, suspected of lung cancer and referred to a lung
physician in one of the participating centers are included in the study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Aged 18 or above and suspected of having lung cancer
Exclusion Criteria:
- Presence of another malignant tumor, i.e. diagnosed with a tumor in the past 5 years
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zuyderland Medical Center
Address:
City:
Heerlen
Zip:
6419PC
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Michiel Gronenschild, MD
Facility:
Name:
Maastricht University Medical Center
Address:
City:
Maastricht
Zip:
6229HX
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Lizza Hendriks, MD, PhD
Facility:
Name:
Catharina Ziekenhuis Eindhoven
Address:
City:
Eindhoven
Zip:
5623EJ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Hao Cao, MSc
Phone:
+31402398644
Email:
hao.cao@catharinaziekenhuis.nl
Facility:
Name:
St. Anna Ziekenhuis
Address:
City:
Geldrop
Zip:
5664EH
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Gerben Stege, MD, PhD
Facility:
Name:
Máxima Medisch Centrum
Address:
City:
Veldhoven
Zip:
5504DB
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Magdolen El Soud-Youssef, MD
Start date:
October 31, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Catharina Ziekenhuis Eindhoven
Agency class:
Other
Collaborator:
Agency:
Eindhoven University of Technology
Agency class:
Other
Collaborator:
Agency:
Roche BV Netherlands
Agency class:
Other
Collaborator:
Agency:
Maxima Medical Center
Agency class:
Other
Collaborator:
Agency:
Zuyderland Medisch Centrum
Agency class:
Other
Collaborator:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
St. Anna Ziekenhuis, Geldrop, Netherlands
Agency class:
Other
Collaborator:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Source:
Catharina Ziekenhuis Eindhoven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06105177
https://richtlijnendatabase.nl/richtlijn/kleincellig_longcarcinoom/kleincellig_longcarcinoom_-_startpagina.html
https://richtlijnendatabase.nl/richtlijn/niet_kleincellig_longcarcinoom/startpagina_-_niet-kleincellig_longcarcinoom.html
https://pure.tue.nl/ws/portalfiles/portal/190681670/20211214_Kock.pdf
