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NCT Number: NCT02273336

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

Up to 39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytology Specimen Collection Procedure

Other

Undergo tissue and blood sample collection

Other names: cytologic sampling

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. 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

    Time frame: 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.

  2. Proportion of young lung cancer patients that enroll onto clinical trials

    Time frame: Baseline

  3. Proportion of patients that received targeted therapies based on their clinical genotyping results

    Time frame: Baseline

  4. Acquired deactivating mutations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Addario Lung Cancer Medical Institute
  • Foundation Medicine
  • National Cancer Institute (NCI)

Registry information

Official study title

Genomics of Young Lung Cancer Study

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2014
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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