Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
The goal of this study is to demonstrate the feasibility of using a novel, validated panel of Non-Small Cell Lung Cancer (NSCLC) histology-predictive genes (the "A/S signature) as a diagnostic tool for use with small-volume Fine Needle Aspirate (FNA) biopsies.
- To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.
- To define a "fixed statistical model" of histologic subtype prediction in NSCLC.
Study methods: To establish FNA biopsy requirements for gene expression-based subtype classification of NSCLC, patients with presumed newly diagnosed NSCLC, where radiographic studies and clinical description favor a probable diagnosis of NSCLC, will undergo FNA biopsy according to current standard techniques . For this part of the study, approximately 40 biopsies of confirmed NSCLC will be collected for analysis.
To define a fixed statistical model of histologic subtype prediction in NSCLC, we will prospectively collect 50 FNAs. These FNAs will represent Adenocarcinoma (AC) and Squamous Cell Carcinoma (SCC) cases at a ratio of approximately 1:1. Additional cases of not otherwise specified (NOS), should they be encountered, may also be collected for later analysis. FNA samples qualified based on cell number or ribonucleic acid (RNA) yield (depending on the findings of our primary objective)will be assayed on the QGS platform.
Non-Small Cell Lung Cancer
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates|
- Use of Ribonucleic acid-based molecular signature of tumor samples obtained by fine needle aspirate to discriminate subtypes of tumors relevant to treatment and outcomes. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]To test a an 8-gene panel's accuracy in discriminating Non-Small Cell Lung Cancer tumors subtypes that are relevant to treatment and expected outcomes.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
patients newly diagnosed non small cell lung cancer
patients with presumed newly diagnosed non small cell lung cancer, where radiographic studies and clinical description favor a probable diagnosis of non small cell lung cancer
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630122
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Jimmy Ruiz, MD||Wake Forest School of Medicine|