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Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

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ClinicalTrials.gov Identifier: NCT01595074
Recruitment Status : Not yet recruiting
First Posted : May 9, 2012
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
This research trial studies biomarkers in predicting treatment response in samples from patients with early-stage non-small cell lung cancer previously treated with adjuvant chemotherapy. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Condition or disease Intervention/treatment
Stage IA Non-small Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Other: medical chart review Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

I. Validation of the 15-gene prognostic and predictive messenger (m) ribonucleic acid (RNA) signature on Lung Adjuvant Cisplatin Evaluation (LACE)-Bio formalin-fixed, paraffin-embedded tissue (FFPE) tumor samples.

II. Exploratory evaluation of the prognostic and predictive values of known potential oncogenic mutations using LACE-Bio FFPE tumor samples.

III. Exploratory evaluation of the prognostic and predictive values of gene copy variations using LACE-Bio FFPE tumor samples.

IV. Exploratory identification and evaluation of prognostic and predictive value of novel genomic aberrations discovered by Next Generation Sequencing on LACE-Bio tumor samples.

OUTLINE:

Archived RNA and DNA samples are analyzed for gene expression, mutations, and variations by reverse transcriptase (RT)-polymerase chain reaction (qPCR), mass spectrometry (MassARRAY), molecular inversion probe assay, and microarray assays. Results are then compared with patients' clinical outcomes.

Study Design
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Study Type : Observational
Estimated Enrollment : 950 participants
Official Title: The Identification, Validation and Implemention of Prognostic and/or Predictive Biomarkers for Adjuvant Chemotherapy in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : May 2012
Estimated Primary Completion Date : January 2100

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Ancillary-Correlative (laboratory biomarkre analysis)
Archived RNA and DNA samples are analyzed for gene expression, mutations, and variations by RT-qPCR, MassARRAY, molecular inversion probe assay, and microarray assays. Results are then compared with patients' clinical outcomes.
 Other: medical chart review
Correlative studies
Other Name: chart review

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay [ Time Frame: Post-RNA extraction from tissue ]
  2. Prognostic and predictive value of known potential oncogenic mutations and gene copy variations of novel genomic aberrations on disease free survival (DFS) and overall survival (OS) [ Time Frame: Post-RNA extraction from tissue ]
    Survival curves will be estimated using Kaplan-Meier methods and compared with the log-rank test. The hypothesis of constant risk ratio over time in the Cox proportional hazards (PH) model will be tested by introducing a time-dependent interaction with the marker or using Schoenfeld's residuals.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Criteria

Inclusion Criteria:

  • Samples from patients treated in 4 adjuvant chemotherapy (ACT) for early-stage non-small cell lung cancer (NSCLC) pivotal trials:

    • International Adjuvant Lung Cancer Trail (IALT)
    • Cancer and Leukemia Group B (CALGB)-9633
    • CAN-NCIC-BR10
    • Adjuvant Navelbine International Trialist Association (ANITA)
  • Not specified
  • See Disease Characteristics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595074


Locations
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Canada, Ontario
National Cancer Institute of Canada Clinical Trials Group
Kingston, Ontario, Canada, K7L 3N6
Contact: Lesley K. Seymour    613-533-6430    lseymour@ctg.queensu.ca   
Principal Investigator: Lesley K. Seymour         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lesley Seymour Canadian Cancer Trials Group
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01595074    
Other Study ID Numbers: NCI-2012-01965
LACE-BIO-2#1
CDR0000733532
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms