Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-08 @ 8:08 AM
Study NCT ID:
NCT03123133
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Expression That Predicts Radiation Exposure in Humans
Sponsor:
DxTerity Diagnostics
Organization:
Study Overview
Official Title:
Gene Expression That Predicts Radiation Exposure in Humans
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: