This trial is active, not recruiting.

Condition lung cancer
Treatment laboratory biomarker analysis
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date October 2011
End date January 2100
Trial size 261 participants
Trial identifier NCT01415739, CALGB-151102, CDR0000706383, NCI-2011-02977


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Previously collected tissue samples are analyzed via H&E staining and IHC.
laboratory biomarker analysis
Correlative studies

Primary Outcomes

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

Secondary Outcomes

NSCLC misclassification rate
time frame: 1 month

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of a Novel Molecular NSCLC Classification System
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.