NCT02273336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2020

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

6.1 years

First QC Date

October 21, 2014

Last Update Submit

November 16, 2021

Conditions

Non-small Cell Lung CancerSmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

  • 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

  • Proportion of young lung cancer patients that enroll onto clinical trials

    Baseline

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

    Baseline

  • 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

Study Arms (1)

Ancillary-Correlative (comprehensive genomic analysis)

Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.

Other: cytology specimen collection procedureOther: laboratory biomarker analysis

Interventions

cytology specimen collection procedureOTHER

Undergo tissue and blood sample collection

Also known as: cytologic sampling
Ancillary-Correlative (comprehensive genomic analysis)
laboratory biomarker analysisOTHER

Correlative studies

Ancillary-Correlative (comprehensive genomic analysis)

Eligibility Criteria

AgeUp to 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited at Dana Farber Institute and USC Norris Cancer Center.

You may qualify if:

  • 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

You may not qualify if:

  • Compromise of patient diagnosis or staging if tissue is used for research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Barbara Gitlitz, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 23, 2014

Study Start

July 22, 2014

Primary Completion

August 8, 2020

Study Completion

September 8, 2020

Last Updated

November 18, 2021

Record last verified: 2021-11

Locations

US(2)