Gene Expression That Predicts Radiation Exposure in Humans

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).

Study Overview

• Status: Completed
• Conditions: Total Body Irradiation

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.

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Los Angeles, California, United States, 90024
      • University of California, Los Angeles, Radiation Oncology
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Male and female patients age 2 or older.
2. Weigh at least 13kg (30lbs), and in the opinion of the investigator, are healthy enough to participate in study activities.
3. 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.
4. Diseases treated with HSCT, including malignant and nonmalignant diseases.
5. 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.

Exclusion Criteria:

1. Subjects who have received chemotherapy within 21 days prior to TBI.
2. Concurrent chemotherapy with Fludarabine or an investigational product
3. Cytokine inhibitor or cytokine-inducer therapy within 30 days prior to and during the irradiation regimen
4. Subjects who have received GCSF within 30 days prior to TBI
5. Participants, who in the opinion of the investigator, may not be able to comply with the requirements of the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: DxTerity Diagnostics
• Collaborators: Biomedical Advanced Research and Development Authority
• Investigators: Study Director: Aviva Jacobs, PhD, Director, Product Developement

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2017
• Primary Completion (ACTUAL): April 17, 2020
• Study Completion (ACTUAL): July 14, 2020

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (ACTUAL): April 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DXT-RBT-AB01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No