- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415739
Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer
Evaluation of a Novel Molecular NSCLC Classification System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, Cancer and Leukemia Group B (CALGB) 9761.
SECONDARY OBJECTIVES:
I. To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).
OUTLINE:
Previously collected tissue samples are analyzed via hematoxylin and eosin (H&E) staining and immunohistochemistry (IHC).
Study Type
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Alliance for Clinical Trials in Oncology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients must have been registered on CALGB-9761
- Stage I disease
- Treatment-naive patients
- A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office
- A separate consent form is not required for this study, as permission for research to be performed on the tissue blocks is included in the consent form for CALGB 9761
- Institutional review board (IRB) review and approval at the institution where the laboratory work will be performed is required
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Novel Molecular NSCLC Classification (H & E staining, IHC)
Previously collected tissue samples are analyzed via H&E staining and IHC.
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Correlative studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Validation of a novel 4-protein signature's ability to subtype NSCLC
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NSCLC misclassification rate
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Daniel J. Boffa, MD, Smilow Cancer Hospital at Yale-New Haven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CALGB-151102
- CDR0000706383 (Registry Identifier: NCI Physician Data Query)
- NCI-2011-02977 (Registry Identifier: NCI Clinical Trial Reporting Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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