Gene Expression That Predicts Radiation Exposure in Humans

NCT03123133 | Completed

• 1 other identifier: DXT-RBT-AB01
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 3

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).

Conditions

Total Body Irradiation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• DxTerity Diagnostics: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

Location

University of California, Los Angeles, Radiation Oncology

Los Angeles, California, 90024, United States

Location

Fred Hutch Cancer Research Center

Seattle, Washington, 98109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for genomic analysis

Study Officials

• Aviva Jacobs, PhD

  Director, Product Developement

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 21, 2017
• Study Start: April 6, 2017
• Primary Completion: April 17, 2020
• Study Completion: July 14, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)