Status:
COMPLETED
Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Foundation Medicine
Addario Lung Cancer Medical Institute
Conditions:
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Eligibility:
All Genders
Up to 39 years
Brief Summary
This research trial studies genomic analysis in tissue and blood samples from young patients with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid \[DNA\]) may help d...
Detailed Description
PRIMARY OBJECTIVES: I. To perform comprehensive genomic analysis of young lung cancer patients' samples to facilitate delivery of targeted therapies and clinical trial enrollment. II. To characteriz...
Eligibility Criteria
Inclusion
- COHORT 1: LUNG CANCER PATIENTS
- 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
- Compromise of patient diagnosis or staging if tissue is used for research
Key Trial Info
Start Date :
July 22 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 8 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02273336
Start Date
July 22 2014
End Date
September 8 2020
Last Update
November 18 2021
Active Locations (2)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115