- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250404
Molecular Signatures of Relapse in Tissue Samples From Patients With Small Cell Lung Cancer Who Are Receiving Cisplatin and Etoposide
May 23, 2018 updated by: University of Southern California
Pilot Study of the Identification of the Molecular Signatures of Relapse in Small Cell Lung Cancer
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90033
- Los Angeles County-USC Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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.
|
Correlative studies
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Barbara Gitlitz, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2014
Primary Completion (Anticipated)
August 22, 2018
Study Completion (Anticipated)
August 22, 2019
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
September 23, 2014
First Posted (Estimate)
September 26, 2014
Study Record Updates
Last Update Posted (Actual)
May 25, 2018
Last Update Submitted That Met QC Criteria
May 23, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2O-13-1 (Other Identifier: USC Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2014-01910 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- HS-14-00382
- UL1TR000130 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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