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


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome 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.

Outcome Description:

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.

Outcome Time Frame:

Day 1

Safety Issue:

No

Principal Investigator

Jimmy Ruiz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 97112

NCT ID:

NCT01630122

Start Date:

June 2012

Completion Date:

June 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Trans-thoracic Needle Biopsy (TNB)
  • Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)
  • Trans-esophageal Ultrasound Scanning with FNA (EUS-FNA)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157