Gene Expression That Predicts Radiation Exposure in Humans

Sponsor
DxTerity Diagnostics (Industry)
Overall Status
Completed
CT.gov ID
NCT03123133
Collaborator
Biomedical Advanced Research and Development Authority (U.S. Fed)
151
3
39.3
50.3
1.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    151 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Gene Expression That Predicts Radiation Exposure in Humans
    Actual Study Start Date :
    Apr 6, 2017
    Actual Primary Completion Date :
    Apr 17, 2020
    Actual Study Completion Date :
    Jul 14, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Collection of a sufficient number of blood samples to enable clinical validation of the RBT [Up to approximately 1 month, from informed consent through completion of blood sample and data collection activities]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 University of California, Los Angeles, Radiation Oncology Los Angeles California United States 90024
    3 Fred Hutch Cancer Research Center Seattle Washington United States 98109

    Sponsors and Collaborators

    • DxTerity Diagnostics
    • Biomedical Advanced Research and Development Authority

    Investigators

    • Study Director: Aviva Jacobs, PhD, Director, Product Developement

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DxTerity Diagnostics
    ClinicalTrials.gov Identifier:
    NCT03123133
    Other Study ID Numbers:
    • DXT-RBT-AB01
    First Posted:
    Apr 21, 2017
    Last Update Posted:
    Apr 21, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 21, 2021