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Spots Global Cancer Trial Database for Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer

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Trial Identification

Brief Title: Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer

Official Title: Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer

Study ID: NCT03512847

Interventions

Study Description

Brief Summary: The study aims include: * Exploring potential predictive molecular profiles to immunotherapy/chemotherapy * Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy * Identifying possible resistance mechanisms to immunotherapy/chemotherapy Materials and methods: Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or chemotherapy will be candidates for inclusion during a 1-2 years period. A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive disease during/after first line treatment, patients will be asked to participate in a new biopsy and a comprehensive molecular profiling will be performed. The tissue and blood samples collected will be stored in a biobank. Clinical data will be collected to perform a comprehensive database. Analysis: Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by comparison of treatment outcome for patients with specific molecular characteristics. Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a dynamic biomarker will be further strengthened. Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to treatment. Molecular profiling on progression can be valuable in second-line treatment guidance.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Oncology, Naestved, Zealand, Denmark

Contact Details

Name: Frank S Malene, MD

Affiliation: Region Zeland

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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