Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer

Plain-language summary

This study investigates comprehensive genetic (genomic) analysis of tumor and blood samples in young lung cancer patients. It included patients with pathologically confirmed small cell or non-small cell lung cancer. It is an observational (non-phase) study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

University of Southern California

Intervention

cytology specimen collection procedure, laboratory biomarker analysis

Start date

7/22/2014

Estimated completion

9/8/2020

Countries

United States

Related genes

Locations

• Los Angeles, United States
• Boston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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 Criteria:

* Compromise of patient diagnosis or staging if tissue is used for research