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Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182155
First Posted: August 16, 2010
Last Update Posted: July 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
August 12, 2010
August 16, 2010
July 1, 2016
August 2010
September 2011   (Final data collection date for primary outcome measure)
Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements [ Time Frame: Every 3 months for 1 year ]
Same as current
Complete list of historical versions of study NCT01182155 on ClinicalTrials.gov Archive Site
Pre and post-radiation CO (carbon monoxide), CO2 (carbon dioxide), and N2O (nitrous oxide) measurements and feasibility as the fraction of patients unable to give a breath sample. Adverse events are not expected but any that appear related to the breath [ Time Frame: 1 yr ]
Same as current
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Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation
Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation: A Feasibility Study
Patients treated with radiation therapy for lung tumors can experience inflammation after treatment. This study hopes to evaluate the use of breath analysis to evaluate changes in the composition of exhaled breath in patients undergoing radiotherapy. If changes can be detected, this may ultimately serve as biomarkers for identifying patients at highest risk for radiation-induced lung injury (radiation pneumonitis).
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients with lung tumors who are undergoing radiation therapy
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Small Cell Lung Cancer
Procedure: Exhaled Breath Sampling
Standard of care
Other Name: breath gas analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2012
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of any type of lung tumor
  • Medical recommendation (independent of the study) that the patient undergo thoracic radiation therapy. Radiation therapy may be either fractionated or hypofractionated (i.e. radiosurgery)
  • Age >= 18 years old
  • Any gender and any ethnic background will be recruited
  • Capable of giving written informed consent

Exclusion Criteria:

  • Inability of giving written informed consent
  • Pregnancy or breast-feeding
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01182155
LUN0043
SU-08102010-6705 ( Other Identifier: Stanford University )
Yes
Not Provided
Not Provided
Stanford University
Stanford University
Not Provided
Principal Investigator: Dr. Maximilian Diehn MD/PhD Stanford University
Stanford University
June 2016