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

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.
 
ClinicalTrials.gov Identifier: NCT01182155
Recruitment Status : Completed
First Posted : August 16, 2010
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Lung Cancer Non-Small Cell Lung Cancer Small Cell Lung Cancer Procedure: Exhaled Breath Sampling

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation: A Feasibility Study
Study Start Date : August 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: Exhaled Breath Sampling
    Standard of care
    Other Name: breath gas analysis

Outcome Measures
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Primary Outcome Measures :
  1. Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements [ Time Frame: Every 3 months for 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lung tumors who are undergoing radiation therapy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182155


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Dr. Maximilian Diehn MD/PhD Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01182155    
Other Study ID Numbers: LUN0043
SU-08102010-6705 ( Other Identifier: Stanford University )
First Posted: August 16, 2010    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Keywords provided by Stanford University:
Lung Cancer Non-Small Cell Cancer (NSCLC)
Lung Cancer Small Cell Lung Cancer (SCLC)
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms