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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273336
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : November 18, 2021
Sponsor:
Collaborators:
Foundation Medicine
Addario Lung Cancer Medical Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date October 21, 2014
First Posted Date October 23, 2014
Last Update Posted Date November 18, 2021
Actual Study Start Date July 22, 2014
Actual Primary Completion Date August 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2014)
  • 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.
  • Proportion of young lung cancer patients that enroll onto clinical trials [ Time Frame: Baseline ]
  • Proportion of patients that received targeted therapies based on their clinical genotyping results [ Time Frame: Baseline ]
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer
Official Title Genomics of Young Lung Cancer Study
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and tissue
Sampling Method Non-Probability Sample
Study Population Subjects will be recruited at Dana Farber Institute and USC Norris Cancer Center.
Condition
  • Non-small Cell Lung Cancer
  • Small Cell Lung Cancer
Intervention
  • Other: cytology specimen collection procedure
    Undergo tissue and blood sample collection
    Other Name: cytologic sampling
  • Other: laboratory biomarker analysis
    Correlative studies
Study Groups/Cohorts Ancillary-Correlative (comprehensive genomic analysis)
Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
Interventions:
  • Other: cytology specimen collection procedure
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 12, 2018)
40
Original Estimated Enrollment
 (submitted: October 21, 2014)
60
Actual Study Completion Date September 8, 2020
Actual Primary Completion Date August 8, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 39 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02273336
Other Study ID Numbers ALCMI-003
NCI-2014-02098 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2L-14-1
ALCMI-003 ( Other Identifier: USC Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Southern California
Study Sponsor University of Southern California
Collaborators
  • Foundation Medicine
  • Addario Lung Cancer Medical Institute
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara Gitlitz, MD University of Southern California
PRS Account University of Southern California
Verification Date November 2021