Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01517971
First received: January 20, 2012
Last updated: July 23, 2015
Last verified: July 2015

January 20, 2012
July 23, 2015
January 2012
June 2100   (final data collection date for primary outcome measure)
Recurrence [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Development and validation of a molecular prognostic signature for worse or good survival [ Designated as safety issue: No ]
  • 36-month survival rate for each risk group using Kaplan-Meier survival analyses [ Designated as safety issue: No ]
  • Statistical significance of the association between a specific signature and disease-free survival or overall survival [ Designated as safety issue: No ]
  • Validation of prognostic signatures and classifiers for stage IB and stage II NSCLC [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01517971 on ClinicalTrials.gov Archive Site
  • Cancer specific survival [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Probability of death due to other causes [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer
Validation of Molecular Prognostic Tests in NSCLC

This research trial studies biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict how well patients will respond to treatment.

PRIMARY OBJECTIVES:

I. To develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (RNA)-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1B non-small cell lung cancer (NSCLC) (T2aN0M0) by predicting the risk of cancer recurrence after surgery.

SECONDARY OBJECTIVES:

I. To develop and validate a clinically useful prognostic signature for stage 1A NSCLC (T1a-bN0M0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective.

II. To determine the effects on test accuracy of the histological subtype (adenocarcinoma [AC] vs squamous cell [SQA]) for each of the stage specific prognostic classifiers.

III. To determine the relevant statistical features, including accuracy of predicting overall survival, cancer specific survival, and disease free survival at 3 and 5 years, for each of the prognostic classifiers validated.

IV. To utilize the validated prognostic signatures and classifiers in stage 1B NSCLC to determine whether these can reliably predict good outcome among stage II NSCLC patients.

OUTLINE:

RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression by Affymetrix microarrays (Gene Profiling Array cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR).

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Tissue samples

Probability Sample

Patients diagnosed with NSCLC enrolled on the Cancer and Leukemia Group B (CALGB) 140202

Lung Cancer
Other: laboratory biomarker analysis
Correlative studies
Ancillary-correlative (whole-genome expression)
RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Gene Profiling Array cGMP U133 P2 and RT-PCR.
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1060
Not Provided
June 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Registration to CALGB-140202
  • The subject population to be studied in this protocol includes patients selected from CALGB-140202; all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial; the CALGB does not require that a separate consent form be signed for this study
  • All samples to be studied were obtained and stored as part of CALGB-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
  • Tumor specimens need to have 40% tumor content to be included
Both
18 Years and older
No
Contact: Raphael Bueno, MD 617-732-8148
United States
 
NCT01517971
CALGB-150807, CALGB-150807, CDR0000720368
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Raphael Bueno, MD Dana-Farber/Brigham and Women's Cancer Center
Alliance for Clinical Trials in Oncology
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP