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

Withdrawn

• Conditions: Small Cell Lung Cancer
• Interventions: Other: cytology specimen collection procedure; Other: laboratory biomarker analysis

• Registration Number: NCT02250404
• Lead Sponsor: University of Southern California

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08-22
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-26
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25
• Primary Completion: 2018-08-22
• Study Completion: 2019-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (molecular profile)	laboratory biomarker analysis	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.
Ancillary-Correlative (molecular profile)	cytology specimen collection procedure	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Los Angeles County-USC Medical Center; 🇺🇸 Los Angeles, California, United States

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States