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Gene Expression That Predicts Radiation Exposure in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123133
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
DxTerity Diagnostics

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
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.

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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 : April 6, 2017
Actual Primary Completion Date : April 17, 2020
Actual Study Completion Date : July 14, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Collection of a sufficient number of blood samples to enable clinical validation of the RBT [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Whole blood for genomic analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123133


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
University of California, Los Angeles, Radiation Oncology
Los Angeles, California, United States, 90024
United States, Washington
Fred Hutch Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
DxTerity Diagnostics
Biomedical Advanced Research and Development Authority
Investigators
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Study Director: Aviva Jacobs, PhD Director, Product Developement
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Responsible Party: DxTerity Diagnostics
ClinicalTrials.gov Identifier: NCT03123133    
Other Study ID Numbers: DXT-RBT-AB01
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No