Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates

NCT01630122 | Completed

• 2 other identifiers: IRB00020151CCCWFU 97112
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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. 1.To establish FNA biopsy requirements for FNA-based subtype classification of NSCLC.
2. 2.To define a "fixed statistical model" of histologic subtype prediction in NSCLC.

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Day 1

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• Patients whose FNA biopsy is unable to provide subtype classification by pathology or is non-diagnostic.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jimmy Ruiz, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 28, 2012
• Study Start: June 1, 2012
• Primary Completion: August 18, 2015
• Study Completion: August 18, 2015
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)