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NCT01415739 Clinical Trial

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

Lung Cancer Clinical Trial

Official title:
Evaluation of a Novel Molecular NSCLC Classification System

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01415739
Other study ID # CALGB-151102
Secondary ID CDR0000706383NCI
Status Withdrawn
Phase
First received
Last updated
Start date October 2011
Est. completion date August 2015

Study information
Verified date January 2019
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations
Country Name City State
United States Alliance for Clinical Trials in Oncology Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of a novel 4-protein signature's ability to subtype NSCLC 1 month
Secondary NSCLC misclassification rate 1 month
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