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NCT02250404 Clinical Trial

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

Small Cell Lung Cancer Clinical Trial

Official title:
Pilot Study of the Identification of the Molecular Signatures of Relapse in Small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02250404
Other study ID # 2O-13-1
Secondary ID NCI-2014-01910HS
Status Withdrawn
Phase
First received
Last updated
Start date August 22, 2014
Est. completion date August 22, 2019

Study information
Verified date May 2018
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 22, 2019
Est. primary completion date August 22, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• cytology specimen collection procedure
Correlative studies
• laboratory biomarker analysis
Correlative studies

Locations
Country Name City State
United States Los Angeles County-USC Medical Center Los Angeles California
United States USC Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in tumor tissue molecular profiles Profiles of pre- and post-relapse tumor tissue will be compared. Data will be compared with mouse data and overlaps determined. Baseline to up to 1 year
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