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

University of Southern California

Status: Completed

Conditions: Small Cell Lung Cancer; Non-small Cell Lung Cancer

Treatments: Other: laboratory biomarker analysis; Other: cytology specimen collection procedure

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT02273336

ALCMI-003 (Other Identifier)

NCI-2014-02098 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

2L-14-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: Under 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Ancillary-Correlative (comprehensive genomic analysis)

Description:

Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.

Treatment:

Other: cytology specimen collection procedure

Other: laboratory biomarker analysis