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

Completed

• Conditions: Small Cell Lung Cancer; Non-small Cell Lung Cancer
• Interventions: Other: cytology specimen collection procedure; Other: laboratory biomarker analysis

• Registration Number: NCT02273336
• Lead Sponsor: University of Southern California

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

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07-22
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Primary Completion: 2020-08-08
• Study Completion: 2020-09-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (comprehensive genomic analysis)	cytology specimen collection procedure	Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
Ancillary-Correlative (comprehensive genomic analysis)	laboratory biomarker analysis	Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.

Primary Outcome Measures

Name	Time	Method
Proportion of patients that received targeted therapies based on their clinical genotyping results	Baseline
Proportion of young lung cancer patients that enroll onto clinical trials	Baseline
Acquired deactivating mutations	Baseline	All data summaries based on next generation sequencing of tumor and blood deoxyribonucleic acid/ribonucleic acid will be descriptive, with the goal of discovering novel tumor suppressor genes that may be deactivated leading to the development of NSCLC in individuals less than 40 years.
Prevalence of targetable mutations, defined as any alteration in a drive oncogene for which Food and Drug Administration-approved therapy exists, for which an off-label therapy exists, or for which a clinical trial exists	Baseline	Will compare this population with the historical experience of the Lung Cancer Mutation Consortium. For this specific comparison, the prevalence of mutations in EGFR, ALK, v-raf murine sarcoma viral oncogene homolog B1 (BRAF), human epidermal growth factor receptor 2 (HER2), v-ros avian UR2 sarcoma virus oncogene homolog 1 (ROS1), and met proto-oncogene (MET) will be calculated.

Trial Locations

Locations (2)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States