Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
Foundation Medicine
Addario Lung Cancer Medical Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Small Cell Lung Cancer Other: cytology specimen collection procedure Other: laboratory biomarker analysis

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Genomics of Young Lung Cancer Study
Actual Study Start Date : July 22, 2014
Estimated Primary Completion Date : July 22, 2020
Estimated Study Completion Date : July 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood and tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited at Dana Farber Institute and USC Norris Cancer Center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273336


Locations
Layout table for location information
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
University of Southern California
Foundation Medicine
Addario Lung Cancer Medical Institute
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Barbara Gitlitz, MD University of Southern California

Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02273336     History of Changes
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 )
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms