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

Evaluation of a Novel Molecular NSCLC Classification System

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01415739

Enrollment

Registered

2011-08-12

Start date

2011-10-31

Completion date

2015-08-31

Last updated

2019-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer

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.

Detailed description

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).

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Validation of a novel 4-protein signature's ability to subtype NSCLC	1 month

Secondary

Measure	Time frame
NSCLC misclassification rate	1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026