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

Withdrawn

• Conditions: Lung Cancer
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01415739
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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).

Study Timeline

• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Study Start: 2011-10
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novel Molecular NSCLC Classification (H & E staining, IHC)	laboratory biomarker analysis	Previously collected tissue samples are analyzed via H\&E staining and IHC.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
NSCLC misclassification rate	1 month

Trial Locations

Locations (1)

Alliance for Clinical Trials in Oncology; 🇺🇸 Boston, Massachusetts, United States