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Mutational Analysis of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Specimens in Patients With Advanced Non-small Cell Lung Cancer: a Randomized Trial of Rapid On-site Evaluation


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

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Trial Information

Mutational Analysis of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Specimens in Patients With Advanced Non-small Cell Lung Cancer: a Randomized Trial of Rapid On-site Evaluation


Inclusion Criteria:



- Age > 18 years

- Suspected hilar or mediastinal lymph node metastasis from lung cancer

Exclusion Criteria:

- Pregnancy

- Uncontrolled coagulopathy

- Refusal to sign informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes

Outcome Description:

Percentage of patients for whom the mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes on EBUS-TBNA samples is obtained

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Rocco Trisolini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maggiore Hospital, Bologna, Italy

Authority:

Italy: Ethics Committee

Study ID:

13001-Trisolini

NCT ID:

NCT01799382

Start Date:

February 2013

Completion Date:

September 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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