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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01517971
First received: January 20, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research studies tumor tissue samples from patients with early- stage non-small cell lung cancer.


Condition Intervention
Lung Cancer
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Official Title: Validation of Molecular Prognostic Tests in NSCLC

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1060
Study Start Date: January 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To develop and validate a clinically useful molecular prognostic signature based on 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

  • 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.
  • 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.
  • 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.
  • 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: This is a multicenter study.

RNA extracted from archived tumor tissue samples are analyzed for whole-genome expression profiling by Affymetrix Gene Profiling Array (cGMP U133 P2) and reverse transcriptase-polymerase chain reaction (RT-PCR). Results are then compared and validated with molecular prognostic signatures that already exist, patients demographics, clinical characteristics, treatment received, and outcomes. A new prognostic signature is then constructed and incorporated into combined classifiers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Patients must have been registered on CALGB-140202
  • The subject population to be studied in this protocol includes patients selected from CALGB-140202

    • Stage IA or IB non-small cell lung cancer
    • Preoperative chemotherapy or radiation-naïve patients' specimens only
    • Full annotation of histological (path report showing margins, histology, differentiation, lymphovascular invasion, etc.), demographic (age, smoking history, and gender), clinical (type of surgery in terms of extent of resection, peri-operative mortality), and follow-up information (recurrence, death, survival, additional chemotherapy/radiotherapy, and adjuvant therapy type and timing) will be required
  • 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
  • No specimens from patients who died during their peri-operative period (30 days or within same admission) from post-operative complications

PATIENT CHARACTERISTICS:

  • No known infectious disease, such as human immunodeficiency virus (HIV)

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517971

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Raphael Bueno, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01517971     History of Changes
Other Study ID Numbers: CDR0000720368, CALGB-150807
Study First Received: January 20, 2012
Last Updated: January 20, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014