This trial is active, not recruiting.

Condition non-small cell lung cancer
Sponsor Wake Forest University Health Sciences
Start date June 2012
End date April 2016
Trial size 103 participants
Trial identifier NCT01630122, CCCWFU 97112


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.


1. To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.

2. 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
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

Primary Outcomes

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

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Patients undergoing a diagnostic FNA by the following diagnostic modalities utilizing FNA: Trans-thoracic Needle Biopsy (TNB), Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA), Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA). - Patients must have radiographic evidence for presumed lung cancer or have a previously diagnosed NSCLC with potential recurrence. Patient undergoing FNA of potential NSCLC metastatic lesions are also included (e.g., patients with hepatic metastases). - Age >18 years. Used to define adult age who can independently provide consent. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - Patients whose FNA biopsy is unable to provide subtype classification by pathology or is non-diagnostic.

Additional Information

Official title Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
Principal investigator Jimmy Ruiz, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Wake Forest University Health Sciences.