Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/26/2019 |
| Start Date: | July 2008 |
| Contact: | Stephen Garziano, MD |
| Phone: | 315-464-4353 |
Participation in the Lung Adjuvant Cisplatin Evaluation Biological Program (LACE-BIO). A Study of Prognostic and Predictive Markers in Early Stage Non-Small Cell Lung Cancer
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.
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.
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.
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.
Inclusion Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
