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The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)


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

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Trial Information

The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Any subject with presumed or known potentially resectable NSCLC

- Due to the nature of NSCLC, children (<18 year of age) will not be considered

- Men, women, and minorities

- Subjects must be able to safely undergo conscious sedation for the EUS procedure

- Subjects must be surgical candidates

- Subjects must not have an uncorrectable coagulopathy and must be able to refrain from
the used of aspirin one week prior to the EUS

- Patient must provide signed written informed consent

Exclusion Criteria:

- Subjects with a history of previously treated lung, head & neck, or esophageal cancer
are not eligible if the histologic cell type is determined to be the same as what is
biopsied during the EUS-FNA

- Uncorrectable coagulopathy

- Significant co-morbidities such as uncontrolled heart failure, or severe chronic
obstructive pulmonary disease (COPD) that would limit their survivability to surgery

- Evidence of significant active infection (e.g. pneumonia, peritonitis, wound abscess)

- Evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes
mellitus, hypothyroidism, etc.) or cardiac condition

- Evidence of dementia or altered mental status that would prohibit the giving and
understanding of informed consent, and no evidence of psychiatric illness that would
preclude adequate compliance with this protocol

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Determine the accuracy of EUS in staging NSCLC

Outcome Time Frame:

at the end of the study

Safety Issue:

No

Principal Investigator

Julia LeBlanc, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

0306-37

NCT ID:

NCT00577746

Start Date:

June 2006

Completion Date:

December 2014

Related Keywords:

  • Non Small Cell Lung
  • Non Small Cell Lung

Name

Location

Indiana University Medical Center; Clarian Health Indianapolis, Indiana  46202