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

Genomics of Young Lung Cancer Study

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer; Non-small Cell Lung Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Other: cytology specimen collection procedure

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 39 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited at Dana Farber Institute and USC Norris Cancer Center.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-Correlative (comprehensive genomic analysis); Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.	Other: laboratory biomarker analysis; Correlative studies; Other: cytology specimen collection procedure; Undergo tissue and blood sample collection; Other Names: cytologic sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline
Proportion of young lung cancer patients that enroll onto clinical trials		Baseline
Proportion of patients that received targeted therapies based on their clinical genotyping results		Baseline
Acquired deactivating mutations	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI); Foundation Medicine; Addario Lung Cancer Medical Institute
• Investigators: Principal Investigator: Barbara Gitlitz, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2014
• Primary Completion (Actual): August 8, 2020
• Study Completion (Actual): September 8, 2020

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ALCMI-003 (Other Identifier: USC Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2014-02098 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 2L-14-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No