Clinical trial NCT02273336: Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer
Official title: Genomics of Young Lung Cancer Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Small Cell Lung Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Foundation Medicine
name: Addario Lung Cancer Medical Institute
name: National Cancer Institute (NCI)
First posted: 2014-10-23
Enrollment: 40
Sex: ALL
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited at Dana Farber Institute and USC Norris Cancer Center.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline
measure: Proportion of young lung cancer patients that enroll onto clinical trials
timeFrame: Baseline
measure: Proportion of patients that received targeted therapies based on their clinical genotyping results
timeFrame: Baseline
measure: Acquired deactivating mutations
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: University of Southern California
name: Barbara Gitlitz, MD
role: PRINCIPAL_INVESTIGATOR
References: