Evaluation of a Novel Molecular NSCLC Classification System
18 Years
N/A
Both
Lung Cancer
Trial Information
Evaluation of a Novel Molecular NSCLC Classification System
OBJECTIVES:
Primary
- To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer
(NSCLC) in a treatment-naive, multi-institutional cohort, CALGB 9761.
Secondary
- To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial
setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).
OUTLINE: Archived tumor tissue samples are marked for regions appropriate for incorporation
into tissue microarray (TMA) and incubated with a cocktail of primary antibodies. Slides are
then stained and a series of high-resolution monochromatic images are captured by the
PM-2000 ™ microscope of each protein. Score of each specific protein is then calculated by
Automated Quantitative Analysis (AQUA).
A board-certified pathologist with a clinical focus in lung cancer reviews the hematoxylin
and eosin (H&E) and immunohistochemistry (IHC) slides and indicates the specific non-small
cell lung cancer subtype. Results are then compared with the primary reference subtype
captured by CALGB-9761 database.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Validation of a novel 4-protein signature's ability to subtype NSCLC
Safety Issue:
No
Principal Investigator
Daniel J. Boffa, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Smilow Cancer Hospital at Yale-New Haven
Authority:
Unspecified
Study ID:
CDR0000706383
NCT ID:
NCT01415739
Start Date:
July 2011
Completion Date:
Related Keywords:
- Lung Cancer
- stage IA non-small cell lung cancer
- stage IB non-small cell lung cancer
- adenocarcinoma of the lung
- squamous cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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