Total Body IrradiationNCT03123133
Gene Expression That Predicts Radiation Exposure in Humans
An observational study of Total Body Irradiation, run by DxTerity Diagnostics at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Total Body Irradiation
- How many people
- 151 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Apr 2017to 14 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope
Duarte, California, 91010
University of California, Los Angeles, Radiation Oncology
Los Angeles, California, 90024
Fred Hutch Cancer Research Center
Seattle, Washington, 98109
About this study
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).
Read the 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.
- Conditions
- Total Body Irradiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 1 month, from informed consent through completion of blood sample and data collection activities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start6 Apr 2017
- Primary completion17 Apr 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Body IrradiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- DxTerity Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Aviva Jacobs, PhD, Study director, Director, Product Developement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123133
- Sponsor's protocol ID
- DXT-RBT-AB01
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2017
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression That Predicts Radiation Exposure in Humans
- ClinicalTrials.gov ID
- NCT03123133
- Acronym / sponsor ID
- DXT-RBT-AB01
- Conditions
- Total Body Irradiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- DxTerity DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aviva Jacobs, PhD study director
Director, Product Developement
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Body Irradiation, run by DxTerity Diagnostics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.