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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)

Tracking Information
First Submitted Date May 8, 2012
First Posted Date May 9, 2012
Last Update Posted Date September 20, 2013
Study Start Date May 2012
Estimated Primary Completion Date January 2100   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2013)
  • 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 ]
  • 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.
Original Primary Outcome Measures
 (submitted: May 8, 2012)		 Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 8, 2012)
  • 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) using Cox proportional hazards regression and conditional logistic r ...
  • DFS and OS of patients who received adjuvant chemotherapy compared to no chemotherapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers in Predicting Treatment Response in Samples From Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy
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)
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.
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 Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Not Provided
Condition
  • 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
Intervention
  • Other: medical chart review
    Correlative studies
    Other Name: chart review
  • Other: laboratory biomarker analysis
    Correlative studies
Study Groups/Cohorts 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.
Interventions:
  • Other: medical chart review
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 8, 2012)		 950
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date January 2100   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01595074
Other Study ID Numbers NCI-2012-01965
LACE-BIO-2#1
CDR0000733532
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party National Cancer Institute (NCI)
Original Responsible Party Lesley Seymour, NCIC-Clinical Trials Group
Current Study Sponsor National Cancer Institute (NCI)
Original Study Sponsor NCIC Clinical Trials Group
Collaborators Not Provided
Investigators
Principal Investigator: Lesley Seymour Canadian Cancer Trials Group
PRS Account National Cancer Institute (NCI)
Verification Date August 2013