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Study Summary
No. 2006-1061:.......Lung; Solid Tumors......Carlos A. Jimenez......Pulmonary Medicine
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Study Summary Title
Study Summary
Number:		2006-1061
Study Title:Six-minute walk test in the evaluation of patients at high risk for complications from lung resection
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Physician New Patient Referral
Name:Carlos A. JimenezPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Pulmonary MedicineReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-4260
Contact us about clinical trials
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General Information
Disease Group:Lung
Solid Tumors		Supported By:N/A
Phase of Study:Phase IIReturn
Visit:		Not Applicable
Treatment
Agents:		NoneHome Care:Not Applicable
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Not Applicable
Description/
Intervention:		The goal of this clinical research study is to compare the 6-minute walk test
with the exercise stress test, in patients who may have lung surgery.
Researchers want to find out if the 6-minute walk test is as good as the
exercise stress test at predicting possible complications that may occur after
lung surgery.
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Study Objectives / Outcomes
    Primary Objectives

    (1) To assess the correlation of the pre-operative six-minute walk test results with that of the gold standard exercise test with analysis of gas exchange and measurement of oxygen uptake (O2).

    (2) To perform equivalence test of the six-minute walk test compared to the gold standard exercise test.

    Secondary Objectives

    (1) To compare the results of six-minute walk test between patients who underwent surgery who had and did not have post-operative morbidity and mortality.

    (2) Subgroup analysis by pulse oximetry saturation percentage levels.
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Study Status Information
Study Activation / Registration Date:02/23/2007
IRB Review and Approval Date:02/23/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patient's age is between 18-90.

2) Patient has been referred for an oxygen consumption exersise test because they are considered high risk for morbitiy and/or mortality post lung resection

3) Patient must be able to read, understand and provide informed consent.
Exclusion Criteria:1) Patients diagnosed with angina pectoris

2) Patients diagnosed with critical aortic stenosis

3) Patients with unstable gait that persists with use of assistive device

4) Patients unable to walk
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Links
Registration Number: NCT00450125
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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