Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer
NCT ID: NCT02273336
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2014-07-22
2020-09-08
Brief Summary
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Detailed Description
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I. To perform comprehensive genomic analysis of young lung cancer patients' samples to facilitate delivery of targeted therapies and clinical trial enrollment.
II. To characterize the impact of young age at lung cancer diagnosis on the genomic landscape of primary lung cancer.
III. To establish a prospective registry of young lung cancer patients for both tumor and germline next generation sequencing.
OUTLINE:
Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
After completion of study, patients are followed up every 3 months for up to 3 years.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ancillary-Correlative (comprehensive genomic analysis)
Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
cytology specimen collection procedure
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laboratory biomarker analysis
Correlative studies
Interventions
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cytology specimen collection procedure
Undergo tissue and blood sample collection
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed bronchogenic lung carcinoma (small cell lung cancer \[SCLC\] or non-small cell lung cancer \[NSCLC\] of any stage) at any treatment time point
* For individuals diagnosed with advanced disease (stage IV or recurrent) enrollment must occur within 2 years of diagnosis
* For appropriate patients (stage IV non-squamous NSCLC) epidermal growth factor receptor (EGFR ) and anaplastic lymphoma kinase (ALK) genotyping performed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is recommended prior to participation
* Provision of written informed consent
* Willingness to undergo a single blood draw
* Individuals who are under 18 are eligible for study if they meet the defined criteria for cohort 1; in addition, consent for participation must be given by a legal guardian or parent
* NOTE: to be eligible for genomics, availability of 10 unstained slides (plus hematoxylin and eosin \[H\&E\] slide) or an adequate formalin-fixed paraffin-embedded (FFPE) tumor block from clinically indicated interventional procedures is required
* COHORT 2: DECEASED INDIVIDUALS
* Deceased individuals diagnosed with lung cancer at any age less than 40 may be studied on a case by case basis depending upon Institutional Review Board (IRB) approval at a participating institution; inclusion will require availability of adequate archived FFPE tissue and release of tissue and records by next of kin, if available
Exclusion Criteria
39 Years
ALL
No
Sponsors
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Foundation Medicine
INDUSTRY
Addario Lung Cancer Medical Institute
OTHER
National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Barbara Gitlitz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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NCI-2014-02098
Identifier Type: REGISTRY
Identifier Source: secondary_id
2L-14-1
Identifier Type: -
Identifier Source: secondary_id
ALCMI-003
Identifier Type: OTHER
Identifier Source: secondary_id
ALCMI-003
Identifier Type: -
Identifier Source: org_study_id