Gene Expression That Predicts Radiation Exposure in Humans
Completed
Conditions studied: Total Body Irradiation
In brief
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).
Key facts
- Study ID
- NCT03123133
- Run by
- DxTerity Diagnostics
- People needed
- 151
- Starts
- 2017-04-06
- Expected to finish
- 2020-07-14
- Last updated by the study team
- 2021-04-21
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female patients age 2 or older.
- Weigh at least 13kg (30lbs), and in the opinion of the investigator, are healthy enough to participate in study activities.
- Evidence of a personally signed and dated informed consent/assent document indicating that the subject or a legally acceptable representative (parent(s)/legal guardian) has been informed of all pertinent aspects of the study.
- Diseases treated with HSCT, including malignant and nonmalignant diseases.
- Planned fractionated total body irradiation (TBI) as part of clinical care with a cumulative dose ≥6 Gy or a single dose between 1.5 and 3.0 Gy.
You may not qualify if…
- Subjects who have received chemotherapy within 21 days prior to TBI.
- Concurrent chemotherapy with Fludarabine or an investigational product
- Cytokine inhibitor or cytokine-inducer therapy within 30 days prior to and during the irradiation regimen
- Subjects who have received GCSF within 30 days prior to TBI
- Participants, who in the opinion of the investigator, may not be able to comply with the requirements of the study.
Where it is running
- City of Hope — Duarte, California, United States
- University of California, Los Angeles, Radiation Oncology — Los Angeles, California, United States
- Fred Hutch Cancer Research Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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