MedTrace Logo

Implementation of Up-front ctDNA Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - LM² Study

NCT06105177 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Eindhoven University of Technology

    collaborator OTHER

  • Roche BV Netherlands

    collaborator UNKNOWN

  • Maxima Medical Center

    collaborator OTHER

  • Zuyderland Medisch Centrum

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • St. Anna Ziekenhuis, Geldrop, Netherlands

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    lead OTHER

Principal Investigators

  • Volkher Scharnhorst, Prof.Dr. · Catharina Ziekenhuis Eindhoven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105177 on ClinicalTrials.gov