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

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ClinicalTrials.gov Identifier: NCT01415739
Recruitment Status : Active, not recruiting
First Posted : August 12, 2011
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Lung Cancer Other: laboratory biomarker analysis

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).

Study Design

Study Type : Observational
Estimated Enrollment : 261 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of a Novel Molecular NSCLC Classification System
Study Start Date : October 2011
Estimated Primary Completion Date : January 2100

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Validation of a novel 4-protein signature's ability to subtype NSCLC [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. NSCLC misclassification rate [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01415739     History of Changes
Other Study ID Numbers: CALGB-151102
CDR0000706383 ( Registry Identifier: NCI Physician Data Query )
NCI-2011-02977 ( Registry Identifier: NCI Clinical Trial Reporting Program )
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

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