- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01182155
Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation
June 30, 2016 updated by: Stanford University
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with lung tumors who are undergoing radiation therapy
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements
Time Frame: Every 3 months for 1 year
|
Every 3 months for 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 yr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Maximilian Diehn MD/PhD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 12, 2010
First Submitted That Met QC Criteria
August 13, 2010
First Posted (Estimate)
August 16, 2010
Study Record Updates
Last Update Posted (Estimate)
July 1, 2016
Last Update Submitted That Met QC Criteria
June 30, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUN0043
- SU-08102010-6705 (Other Identifier: Stanford University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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