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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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Not yet recruiting
CT.gov ID
NCT01595074
Collaborator
(none)
950
Enrollment
1
Location

Study Details

Study Description

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 Phase
  • Other: medical chart review
  • Other: laboratory biomarker analysis

Detailed Description

OBJECTIVES:

  1. 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.

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

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

  4. 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

Study Type:
Observational
Anticipated 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 1, 2012
Anticipated Primary Completion Date :
Jan 1, 2100

Arms and Interventions

Arm 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 Names:
  • chart review

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Validation of the 15-gene prognostic and predictive mRNA signature by quantitative Nuclease Protection Assay (qNPA) assay and NanoString assay [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) [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 National Cancer Institute of Canada Clinical Trials Group Kingston Ontario Canada K7L 3N6

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Lesley Seymour, Canadian Cancer Trials Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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
    Last Update Posted:
    Sep 20, 2013
    Last Verified:
    Aug 1, 2013
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Sep 20, 2013