Clinical Impact of EUS in Staging NSCLC
This study has been completed.
Richard L. Roudebush VA Medical Center
Information provided by (Responsible Party):
First received: December 19, 2007
Last updated: September 3, 2014
Last verified: September 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)
Primary Outcome Measures:
- Determine the accuracy of EUS in staging NSCLC [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measure 5-year survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Determine the cost benefit of EUS in staging NSCLC [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
- Measure quality of life in patients that undergo surgery [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2013 (Final data collection date for primary outcome measure)
Those subjects who went to surgery for treatment for their lung cancer.
The subjects who did not go to surgery for treatment of their lung cancer.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Potentially resectable lung cancer subjects see at thoracic oncology clinics and gastroenterolgy lab.
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00577746
|Indiana University Medical Center; Clarian Health
|Indianapolis, Indiana, United States, 46202 |
Richard L. Roudebush VA Medical Center
||Julia LeBlanc, MD, MPH
||Indiana University School of Medicine
No publications provided
History of Changes
|Other Study ID Numbers:
||0306-37, IRB # 0306-37
|Study First Received:
||December 19, 2007
||September 3, 2014
||United States: Institutional Review Board
Keywords provided by Indiana University:
ClinicalTrials.gov processed this record on October 19, 2014