Breath Test for Biomarkers in Humans Receiving Total Body Irradiation
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|ClinicalTrials.gov Identifier: NCT02152722|
Recruitment Status : Unknown
Verified April 2015 by Menssana Research, Inc..
Recruitment status was: Recruiting
First Posted : June 2, 2014
Last Update Posted : April 7, 2015
The effect of radiation on normal tissue varies widely between individuals. Consequently, a test to measure tissue response to radiation could be clinically useful by permitting more accurate titration of dosage in patients undergoing radiotherapy. Also, in view of emerging concerns about possible nuclear terrorism a test for exposure to radiation might also be useful in evaluating victims of a "dirty bomb" explosion. A number of different techniques have been previously reported in epidemiological studies for the estimation of prior radiation exposure. This study explores one approach to estimating radiation exposure by measurement of increased oxidative stress which can be detected by a breath test.
In this study subjects undergoing significant exposure to therapeutic radiation will provide breath samples for analysis in a central laboratory. The hypothesis of the study is that the analysis of these samples will lead to the identification of a set of markers of radiation exposure.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Breath Test for Biomarkers in Humans Receiving Total Body Irradiation|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||November 2016|
Total Body Irradiation Subjects
Subjects undergoing total body irradiation prior to chemotherapy. It is expected that all of these subjects will be receiving ablative radiation prior to bone marrow transplant. Breath will be collected before and after the first radiation exposure on each day of total body irradiation.
- Radiation volatile organic compound (VOC) score [ Time Frame: Each day of radiation exposure at time points between 1 day and 7 days post exposure. ]An algorithm for scoring the radiation exposure based on analysis of breath samples will be developed and applied to each breath sample collected. The hypothesis is that the scores will indicate radiation exposure, specifically exposure to more than 2 Gray at time points between 1 day and 7 days post exposure.
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): NCT02152722
|Contact: Michael Phillips, MDfirstname.lastname@example.org|
|Contact: Peter Kaplan, PhDemail@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Mohammad Khan, M.D.|
|Principal Investigator: Mohammad Khan, M.D.|
|United States, New Jersey|
|Hackensack University Medical Center||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator: Scott Rowly, M.D.|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Principal Investigator: Chris Barker, M.D.|
|Principal Investigator:||Michael Phillips, M.D.||Menssana Research, Inc.|