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

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ClinicalTrials.gov Identifier: NCT01630122
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.


Condition or disease
Non-Small Cell Lung Cancer

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular and Diagnostic Classification of Non-Small Cell Lung Cancer From Fine Needle Aspirates
Actual Study Start Date : June 2012
Actual Primary Completion Date : August 18, 2015
Actual Study Completion Date : August 18, 2015

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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. [ Time Frame: Day 1 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630122


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Jimmy Ruiz, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01630122    
Other Study ID Numbers: IRB00020151
CCCWFU 97112 ( Other Identifier: Wake Forest University Health Sciences )
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Trans-thoracic Needle Biopsy (TNB)
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)
Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA)
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms