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Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: August 11, 2011
Last updated: July 1, 2016
Last verified: July 2016
This research studies protein in tumor samples from patients with non-small cell lung cancer. Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.

Condition Intervention
Lung Cancer
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of a Novel Molecular NSCLC Classification System

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Validation of a novel 4-protein signature's ability to subtype NSCLC [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NSCLC misclassification rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 261
Study Start Date: October 2011
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Novel Molecular NSCLC Classification (H & E staining, IHC)
Previously collected tissue samples are analyzed via H&E staining and IHC.
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:


I. To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, Cancer and Leukemia Group B (CALGB) 9761.


I. To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).


Previously collected tissue samples are analyzed via hematoxylin and eosin (H&E) staining and immunohistochemistry (IHC).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-small cell lung cancer registered on CALGB 9761

Inclusion Criteria:

  • Patients must have been registered on CALGB-9761

    • Stage I disease
    • Treatment-naive patients
  • A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office
  • A separate consent form is not required for this study, as permission for research to be performed on the tissue blocks is included in the consent form for CALGB 9761
  • Institutional review board (IRB) review and approval at the institution where the laboratory work will be performed is required
  Contacts and Locations
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Please refer to this study by its identifier: NCT01415739

United States, Massachusetts
Alliance for Clinical Trials in Oncology
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Daniel J. Boffa, MD Smilow Cancer Hospital at Yale-New Haven
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT01415739     History of Changes
Other Study ID Numbers: CALGB-151102  CDR0000706383  NCI-2011-02977 
Study First Received: August 11, 2011
Last Updated: July 1, 2016
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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on October 27, 2016