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Collection of Blood Samples in Patients With Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03492801
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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Brief Summary:
This pilot research trial studies the collection of blood samples in monitoring tumor specific mutations in patients with non-small cell lung cancer that has spread to other places in the body or cannot be removed by surgery. Collecting blood samples may help measure the changes in lung cancer, better learn methods to track cancer in the bloodstream, and improve cancer treatments.

Condition or disease Intervention/treatment
Stage III Non-Small Cell Lung Cancer AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Stage IIIB Non-Small Cell Lung Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7 Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known.

II. Compare the sensitivity of digital droplet polymerase chain reaction (ddPCR) to that of NGS for detecting the appearance of EGFR T790M mutations in patients treated with an EGFR tyrosine kinase inhibitor.

OUTLINE:

Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longitudinal Monitoring of Tumor Specific Mutations in Patients With Lung Cancer
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 11, 2020
Estimated Study Completion Date : December 11, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Ancillary-Correlative (biospecimen collection)
Patients undergo collection of blood samples at baseline and every 12 weeks for up to 6 times.
 Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Blood sample collection for tumor specific mutations study from patients with non-small cell lung cancer [ Time Frame: Baseline to 3 years ]
    Blood samples collected will be used to evaluate the ability of next generation sequencing (NGS) to monitor the evolution of cancer-specific mutations in patients undergoing treatment for non-small cell lung carcinoma and for whom the molecular profile of the tumor cells prior to treatment is known.


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
Patients who are seen at all the USC facilities who have metastatic or unresectable non-small cell lung carcinoma and will be starting a new line of systemic treatment will be recruited.
Criteria

Inclusion Criteria:

  • A diagnosis of non-small cell lung carcinoma for which the molecular profile of the primary tumor has been obtained from a block of paraffin-embedded, formalin-fixed tissue that remains available
  • Zubrod performance status 0 or 1
  • Patients must have metastatic or unresectable disease and be starting a new line of systemic treatment at the time of enrollment; there are no constraints regarding the time interval between the initial collection of samples for molecular profiling studies at the time of diagnosis prior to treatment and subsequent collections of circulating cell-free deoxyribonucleic acid (DNA) or circulating tumor cells
  • Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
  • Ability to understand and the willingness to sign a written informed consent; Note: There will be no discrimination between type of treatment or whether they are on continuous versus intermittent therapy

Exclusion Criteria:

  • Known severe anemia (hemoglobin [Hb] < 8g/dL)
  • Patients will be excluded if trackable driver mutations are not identified in the primary tumor tissue
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): NCT03492801


Contacts
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Contact: Aaron Mejia 323-409-4355 Aaron.mejia@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Aaron Mejia    323-409-4355    Pamela.ward@med.usc.edu   
Principal Investigator: Pamela Ward, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Pamela Ward, MD University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03492801    
Other Study ID Numbers: 2L-17-1
NCI-2017-02277 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2L-17-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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