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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Stanford University

ClinicalTrials.gov Identifier:

NCT01182155

First received: August 12, 2010

Last updated: April 4, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2010

Last Updated Date

April 4, 2012

Start Date ^ICMJE

August 2010

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements [ Time Frame: Every 3 months for 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01182155 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Breath Analysis for Evaluation of Radiation Exposure in Lung Cancer Patients Treated With Radiation: A Feasibility Study

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with lung tumors who are undergoing radiation therapy

Condition ^ICMJE

Lung Cancer
Non-Small Cell Lung Cancer
Small Cell Lung Cancer

Intervention ^ICMJE

Procedure: Exhaled Breath Sampling

Standard of care

Other Name: breath gas analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01182155

Other Study ID Numbers ^ICMJE

LUN0043, SU-08102010-6705

Has Data Monitoring Committee

Yes

Responsible Party

Stanford University

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dr. Maximilian Diehn MD/PhD

Stanford University

Information Provided By

Stanford University

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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