RecruitingNCT06105177

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

Implementation of Up-front ctDNA Analysis Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - the Lungmarker² Study


Sponsor

Catharina Ziekenhuis Eindhoven

Enrollment

800 participants

Start Date

Oct 31, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Aged 18 or above and suspected of having lung cancer

Exclusion Criteria1

  • Presence of another malignant tumor, i.e. diagnosed with a tumor in the past 5 years

Locations(5)

Zuyderland Medical Center

Heerlen, Limburg, Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

St. Anna Ziekenhuis

Geldrop, North Brabant, Netherlands

Máxima Medisch Centrum

Veldhoven, North Brabant, Netherlands

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NCT06105177


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