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

NCT ID: NCT01415739

Last Updated: 2019-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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

OUTLINE:

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

Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Novel Molecular NSCLC Classification (H & E staining, IHC)

Previously collected tissue samples are analyzed via H\&E staining and IHC.

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel J. Boffa, MD

Role: STUDY_CHAIR

Smilow Cancer Hospital at Yale-New Haven

Locations

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Alliance for Clinical Trials in Oncology

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000706383

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2011-02977

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-151102

Identifier Type: -

Identifier Source: org_study_id

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