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Trial record 7 of 38 for:    small cell lung ca | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by University of Southern California
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT02250404
First received: September 23, 2014
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
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 Intervention
Small Cell Lung Cancer Other: cytology specimen collection procedure Other: laboratory biomarker analysis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Change in tumor tissue molecular profiles [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Tissue

Estimated Enrollment: 3
Actual Study Start Date: August 22, 2014
Estimated Study Completion Date: August 22, 2019
Estimated Primary Completion Date: August 22, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: cytologic sampling
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects seen at USC Norris Comprehensive Cancer Center and at LAC USC Medical Center with histologically confirmed small cell lung cancer will be recruited for this trial.
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02250404

Locations
United States, California
Los Angeles County-USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Barbara J. Gitlitz    323-865-3000    gitlitz@usc.edu   
Principal Investigator: Barbara J. Gitlitz         
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Gina Tse, R.N.    323-865-0514    Gina.Tse@med.usc.edu   
Principal Investigator: Barbara J. Gitlitz         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara Gitlitz University of Southern California
  More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02250404     History of Changes
Other Study ID Numbers: 2O-13-1
NCI-2014-01910 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
HS-14-00382
2O-13-1 ( Other Identifier: USC Norris Comprehensive Cancer Center )
UL1TR000130 ( U.S. NIH Grant/Contract )
P30CA014089 ( U.S. NIH Grant/Contract )
Study First Received: September 23, 2014
Last Updated: April 11, 2017

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
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on August 23, 2017