Clinical Impact of EUS in Staging NSCLC

NCT ID: NCT00577746

Last Updated: 2014-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2013-09-30

Brief 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.

Conditions

Non Small Cell Lung

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

surgery

Those subjects who went to surgery for treatment for their lung cancer.

No interventions assigned to this group

no surgery

The subjects who did not go to surgery for treatment of their lung cancer.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Richard L. Roudebush VA Medical Center

FED

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia LeBlanc, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Medical Center; Clarian Health

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

IRB # 0306-37

Identifier Type: -

Identifier Source: secondary_id

0306-37

Identifier Type: -

Identifier Source: org_study_id