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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
| Memorial Sloan Kettering Cancer Center | OTHER |
| Emory University | OTHER |
| Hackensack Meridian Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiation volatile organic compound (VOC) score | 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. | Each day of radiation exposure at time points between 1 day and 7 days post exposure. |
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Inclusion Criteria:
Exclusion Criteria:
1. Subject has had chemotherapy within preceding 21 days
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Subjects undergoing total body irradiation prior to chemotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Phillips, MD | Contact | 973-643-5464 | mphillips@menssanaresearch.com | |
| Peter Kaplan, PhD | Contact | 973-643-5464 | pkaplan@menssanaresearch.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Phillips, M.D. | Menssana Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23793046 | Background | 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. |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| OTHER |
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| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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