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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01415739
First received: August 11, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

RATIONALE: 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.

PURPOSE: This research studies protein in tumor samples from patients with non-small cell lung cancer.


Condition Intervention
Lung Cancer
Genetic: microarray analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: staining method

Study Type: Observational
Official Title: Evaluation of a Novel Molecular NSCLC Classification System

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • NSCLC misclassification rate [ Designated as safety issue: No ]

Estimated Enrollment: 261
Study Start Date: July 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

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

OUTLINE: Archived tumor tissue samples are marked for regions appropriate for incorporation into tissue microarray (TMA) and incubated with a cocktail of primary antibodies. Slides are then stained and a series of high-resolution monochromatic images are captured by the PM-2000 ™ microscope of each protein. Score of each specific protein is then calculated by Automated Quantitative Analysis (AQUA).

A board-certified pathologist with a clinical focus in lung cancer reviews the hematoxylin and eosin (H&E) and immunohistochemistry (IHC) slides and indicates the specific non-small cell lung cancer subtype. Results are then compared with the primary reference subtype captured by CALGB-9761 database.

  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-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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01415739

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: Daniel J. Boffa, MD Smilow Cancer Hospital at Yale-New Haven
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01415739     History of Changes
Other Study ID Numbers: CDR0000706383, CALGB-151102
Study First Received: August 11, 2011
Last Updated: August 11, 2011
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 September 16, 2014