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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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To verify and validate a biodosimetry test for determining absorbed ionizing radiation dose by analyzing gene expression signatures of blood samples collected from patients treated with Total Body Irradiation (TBI).
In order validate the performance of DxTerity's Radiation Biodosimetry Test (RBT) system, several clinical centers will provide controlled, de-identified blood samples and associated clinical information to DxTerity Diagnostics (DxTerity). Variations in dose and frequency of delivery in TBI protocols are expected between the clinical centers and this has been accounted for in the study design. Samples from up to 200 participants will be collected via this protocol. Blood samples for this study will be collected from radiation therapy patients receiving TBI as part of a therapeutic regimen from the site.
Blood samples (up to 4 mL per time point) may be obtained at the time of routine blood collection; participation in this biomarker study will not affect any aspect of patient treatment. Study samples will be obtained prior to, during, and post-radiation treatment regimen. Associated clinical information will be collected from the subject's medical record, as well.
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| Measure | Description | Time Frame |
|---|---|---|
| Collection of a sufficient number of blood samples to enable clinical validation of the RBT | Obtain blood samples from 200 TBI patients to analytically validate the Radiation Biodosimetry Test (RBT) System using peripheral blood samples. The RBT should be able to estimate the amount of absorbed radiation that an individual has received from 0 to 10 Gy for up to 7 days post-exposure. | Up to approximately 1 month, from informed consent through completion of blood sample and data collection activities |
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Inclusion Criteria:
Exclusion Criteria:
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Blood samples for this study will be collected from radiation therapy patients receiving TBI as part of a therapeutic regimen from the site. Fractionated TBI treatment will provide a cumulative dose ≥6.0 Gy depending on the specific treatment protocol, or a single non-fractionated dose between 1.5 and 3.0 Gy.
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| Name | Affiliation | Role |
|---|---|---|
| Aviva Jacobs, PhD | Director, Product Developement | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of California, Los Angeles, Radiation Oncology |
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Whole blood for genomic analysis
| Los Angeles |
| California |
| 90024 |
| United States |
| Fred Hutch Cancer Research Center | Seattle | Washington | 98109 | United States |