Clinical trial NCT02152722: Breath Test for Biomarkers in Humans Receiving Total Body Irradiation
Official title: Breath Test for Biomarkers in Humans Receiving Total Body Irradiation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiation Injury
Keywords: Breath test
Volatile Organic Compounds
VOC
oxidative stress
radiation biodosimetry
metabolomics
GCxGC TOF-MS
Lead sponsor: Menssana Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
name: Memorial Sloan Kettering Cancer Center
name: Emory University
name: Hackensack Meridian Health
First posted: 2014-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing total body irradiation prior to chemotherapy.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Subject is willing and able to cooperate with study and give signed informed consent to participate
3. Subject has been diagnosed with a condition that requires treatment with a TBI protocol of daily irradiation for one to five days
4. Actively smoking subjects, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded
5. Subject will be available for follow-up breath tests following each session of TBI. Subjects receiving only one day of TBI will be available for a follow-up 24-36 hours following TBI
6. Subject is an in-patient at the hospital

Exclusion Criteria:

1. Subject has had chemotherapy within preceding 21 days

Primary outcomes:
measure: Radiation volatile organic compound (VOC) score
timeFrame: Each day of radiation exposure at time points between 1 day and 7 days post exposure.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Menssana Research, Inc.
name: Michael Phillips, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phillips M, Byrnes R, Cataneo RN, Chaturvedi A, Kaplan PD, Libardoni M, Mehta V, Mundada M, Patel U, Ramakrishna N, Schiff PB, Zhang X. Detection of volatile biomarkers of therapeutic radiation in breath. J Breath Res. 2013 Sep;7(3):036002. doi: 10.1088/1752-7155/7/3/036002. Epub 2013 Jun 24.