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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512847
Recruitment Status : Active, not recruiting
First Posted : May 1, 2018
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Study Description
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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.


Condition or disease
Metastatic Nonsmall Cell Lung Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Predictive gene profiles [ Time Frame: until progression or death, an average of 3 years ]
    Concordance between specific gene profiles and treatment outcomes

  2. Resistance mechanisms toward chemotherapy and immunotherapy [ Time Frame: until progression or death, an average of 3 years ]
    Differences in molecular profiles pre- and post-treatment

  3. ctDNA as a dynamic biomarker [ Time Frame: until progression or death, an average of 3 years ]
    Quantification of ctDNA during treatment linked to treatment outcome


Biospecimen Retention:   Samples With DNA
Comprehensive molecular profiling. Whole Exome Sequencing

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Metastatic non-small cell lung cancer.
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Able to understand and read Danish
  • WHO Performance status 0-2
  • Acceptable organ function (liver/kidney/heart) for treatment
  • The disease has to be:

evaluable or measurable according to RECIST/iRECIST accessible for biopsy metastatic or not suitable for curative intended treatment

Exclusion Criteria:

  • Other active cancers
  • Contraindications for systemic therapy
  • ALK-positive, ROS-1 or EGFR mutations
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512847


Locations
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Denmark
Department of Oncology
Naestved, Zealand, Denmark
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Frank S Malene, MD Region Zeland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03512847    
Other Study ID Numbers: REG-006-2018
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: February 9, 2022
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
liquid biopsy
genomic profiling
ctDNA
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms