CompletedNot applicableNCT02273336
Official study title

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

Study 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 doctors tailor treatment to target the specific mutations and help plan effective treatment.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedcytology specimen collection procedure and laboratory biomarker analysis

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 18, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?University of Southern California

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Southern California
Interventions being studied
Other: cytology specimen collection procedure; Other: laboratory biomarker analysis
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • USC Norris Comprehensive Cancer CenterLos Angeles, California
  • Dana-Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 18, 2021. Always confirm current availability with the study team.

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