Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
- Conditions
- Lung Cancer
- Interventions
- Other: Laboratory Biomarker Analysis
- Registration Number
- NCT01294280
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
This research trial studies prognostic and predictive markers in patients with early stage non-small cell lung cancer receiving chemotherapy. Prognostic markers are patient or tumor factors that predict patient survival independent of treatment. Predictive markers are factors that may influence and predict the outcome of treatment in terms of either response or survival benefit. Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.
- Detailed Description
PRIMARY OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
-
Registration to CALGB9633 for this study
-
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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-Correlative (IHC) Laboratory Biomarker Analysis Previously collected tissue samples are analyzed by IHC.
- Primary Outcome Measures
Name Time Method Overall survival up to 3 years
- Secondary Outcome Measures
Name Time Method Disease-free survival Up to 3 years
Trial Locations
- Locations (1)
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States