Clincosm LogoSign in Get a demo

Molecular Signatures of Relapse in Tissue Samples From Patients With Small Cell Lung Cancer Who Are Receiving Cisplatin and Etoposide

Sponsor
University of Southern California (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02250404
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
2
Locations
60
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot research trial studies molecular signatures of the return of cancer after a period of improvement (relapse) in tissue samples from patients with small cell lung cancer who are receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from patients with small cell lung cancer in the laboratory may help doctors learn more about the changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer relapse.

Condition or Disease Intervention/Treatment Phase
  • Other: cytology specimen collection procedure
  • Other: laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:
  1. To collect and analyze small cell lung cancer (SCLC) tumor DNA and ribonucleic acid (RNA) from 3 human patients before and after relapse to identify the molecular signatures of relapse.
OUTLINE:

Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at baseline. Patients also undergo collection of tissue samples for analysis at relapse.

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Pilot Study of the Identification of the Molecular Signatures of Relapse in Small Cell Lung Cancer
Actual Study Start Date :
Aug 22, 2014
Anticipated Primary Completion Date :
Aug 22, 2018
Anticipated Study Completion Date :
Aug 22, 2019

Arms and Interventions

Arm Intervention/Treatment
Ancillary-Correlative (molecular profile)

Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at baseline. Patients also undergo collection of tissue samples for analysis at relapse.

Other: cytology specimen collection procedure
Correlative studies
Other Names:
  • cytologic sampling

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in tumor tissue molecular profiles [Baseline to up to 1 year]

      Profiles of pre- and post-relapse tumor tissue will be compared. Data will be compared with mouse data and overlaps determined.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Any patient seen at Norris or County with histologically confirmed SCLC, with tissue in the Norris Cancer Center Tumor Repository

    • Patients must be undergoing or about to start first line treatment with cisplatin and etoposide

    • Patients may not have a second malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    2 USC Norris Comprehensive Cancer Center Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Barbara Gitlitz, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT02250404
    Other Study ID Numbers:
    • 2O-13-1
    • NCI-2014-01910
    • HS-14-00382
    • 2O-13-1
    • UL1TR000130
    • P30CA014089
    First Posted:
    Sep 26, 2014
    Last Update Posted:
    May 25, 2018
    Last Verified:
    May 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of May 25, 2018