NCT03123133

Gene Expression That Predicts Radiation Exposure in Humans

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 151 (actual)
• Sponsor: DxTerity Diagnostics · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Total Body Irradiation

Timeline

• Start date: 2017-04-06
• Primary completion: 2020-04-17
• Completion: 2020-07-14
• First posted: 2017-04-21
• Last updated: 2021-04-21

Locations

3 sites across 1 country: United States