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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Genomics of Young Lung Cancer Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273336
• Other study ID #: ALCMI-003
• Secondary ID: NCI-2014-020982L
• Status: Completed
• Start date: July 22, 2014
• Est. completion date: September 8, 2020

Study information

• Verified date: November 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 8, 2020
• Est. primary completion date: August 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Other:
• cytology specimen collection procedure
Undergo tissue and blood sample collection
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	Addario Lung Cancer Medical Institute, Foundation Medicine, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of young lung cancer patients that enroll onto clinical trials		Baseline
Primary	Proportion of patients that received targeted therapies based on their clinical genotyping results		Baseline
Primary	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