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Molecular Signatures of Relapse in Tissue Samples From Patients With Small Cell Lung Cancer Who Are Receiving Cisplatin and Etoposide
Pilot Study of the Identification of the Molecular Signatures of Relapse in Small Cell Lung Cancer
5 other identifiers
observational
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2014
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 22, 2014
CompletedFirst Submitted
Initial submission to the registry
September 23, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedMay 25, 2018
May 1, 2018
4 years
September 23, 2014
May 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
Correlative studies
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Biospecimen
Tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Gitlitz
University of Southern California
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2014
First Posted
September 26, 2014
Study Start
August 22, 2014
Primary Completion
August 22, 2018
Study Completion
August 22, 2019
Last Updated
May 25, 2018
Record last verified: 2018-05