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
  Purpose

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.


Condition Intervention
Lung Cancer
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validation of Molecular Prognostic Tests in NSCLC

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Recurrence [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Tissue samples


Estimated Enrollment: 1060
Study Start Date: January 2012
Estimated Primary Completion Date: June 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517971

Contacts
Contact: Raphael Bueno, MD 617-732-8148

Locations
United States, Massachusetts
Alliance for Clinical Trials in Oncology Recruiting
Boston, Massachusetts, United States, 02115
Contact: Raphael Bueno, MD    000-000-0000      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Raphael Bueno, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01517971     History of Changes
Other Study ID Numbers: CALGB-150807, CALGB-150807, CDR0000720368
Study First Received: January 20, 2012
Last Updated: July 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA non-small cell lung cancer
stage IB non-small cell lung cancer
adenocarcinoma of the lung
squamous cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on August 27, 2015