Clinical trial NCT01630122: Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
Official title: Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Trans-thoracic Needle Biopsy (TNB)
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)
Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA)
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: 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.

Objectives:

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jimmy Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
References: