Clinical Impact of EUS in Staging NSCLC

Non Small Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577746
• Other study ID #: 0306-37
• Secondary ID: IRB # 0306-37
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: September 3, 2014
• Start date: June 2006
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of this prospective study is to determine the clinical and economic impact of endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo surgery 4) Determine the cost benefit of EUS in staging NSCLC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Non Small Cell Lung

Locations

Country	Name	City	State
United States	Indiana University Medical Center; Clarian Health	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Richard L. Roudebush VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the accuracy of EUS in staging NSCLC		at the end of the study	No
Secondary	Measure 5-year survival		5 years	No
Secondary	Determine the cost benefit of EUS in staging NSCLC		at the end of the study	No
Secondary	Measure quality of life in patients that undergo surgery		at the end of the study	No