Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
NCT ID: NCT01294280
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
241 participants
OBSERVATIONAL
2008-07-31
2016-02-02
Brief Summary
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Detailed Description
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I. Evaluate potential prognostic and predictive markers in patients receiving adjuvant chemotherapy for early stage non-small cell lung cancer (NSCLC).
II. To perform cross-validation analyses for the predictive value of cyclin-dependent kinase inhibitor 1B (p27), excision repair cross-complementation group 1 (ERCC1), beta-tubulin and B-cell lymphoma 2 (BCL2)-associated X protein (BAX).
III. To perform cross-validation analyses for the prognostic value of mucin and breast cancer (BRCA)1 expression.
IV. To perform a pooled analysis for the prognostic impact of p53 protein expression by immunohistochemistry (IHC), tumor protein p53 (p53) mutation, ras mutation and epidermal growth factor receptor (EGFR) mutation, and Fas cell surface death receptor (Fas)/Fas ligand (FasL) expression by IHC.
V. Validation of the 15-gene prognostic and predictive messenger ribonucleic acid (mRNA) signature on Lung Adjuvant Cisplatin Evaluation (LACE)-Bio formalin-fixed paraffin-embedded (FFPE) tumor samples.
VI. Exploratory evaluation of the prognostic and predictive values of known potential oncogenic mutations using LACE-Bio FFPE.
VII. Exploratory evaluation of the prognostic and predictive values of gene copy variation using LACE-Bio FFPE tumor samples.
VIII. Exploratory identification and evaluation of prognostic and predictive value of novel genomic aberrations discovered by Next Generation Sequencing on LACE-Bio tumor samples.
OUTLINE:
Previously collected tissue samples are analyzed by IHC.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Ancillary-Correlative (IHC)
Previously collected tissue samples are analyzed by IHC.
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
* Informed consent:
* The subject population to be studied in this protocol includes patients selected from CALGB 9633 for whom an available specimen is present at the Alliance Ohio State University (OSU); all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
* Only cases with adequate tumor formalin FFPE material without depleting the available clinical block(s) are eligible
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Stephen Graziano, MD
Role: STUDY_CHAIR
State University of New York - Upstate Medical University
Locations
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SUNY Upstate Medical University
Syracuse, New York, United States
Countries
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Other Identifiers
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CDR0000600208
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2009-00454
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-150802
Identifier Type: -
Identifier Source: org_study_id
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