Gene Expression That Predicts Radiation Exposure in Humans
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|ClinicalTrials.gov Identifier: NCT03123133|
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : April 21, 2021
|Condition or disease|
|Total Body Irradiation|
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.
|Study Type :||Observational|
|Actual Enrollment :||151 participants|
|Official Title:||Gene Expression That Predicts Radiation Exposure in Humans|
|Actual Study Start Date :||April 6, 2017|
|Actual Primary Completion Date :||April 17, 2020|
|Actual Study Completion Date :||July 14, 2020|
- Collection of a sufficient number of blood samples to enable clinical validation of the RBT [ Time Frame: Up to approximately 1 month, from informed consent through completion of blood sample and data collection activities ]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.
Biospecimen Retention: Samples With DNA
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): NCT03123133
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|University of California, Los Angeles, Radiation Oncology|
|Los Angeles, California, United States, 90024|
|United States, Washington|
|Fred Hutch Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Director:||Aviva Jacobs, PhD||Director, Product Developement|