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| ID | Type | Description | Link |
|---|---|---|---|
| RSRB00014685 | Other Identifier | University of Rochester IRB |
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This study is to test the effectiveness a new method (called EPR dosimetry) that could be used to measure radiation doses to fingernails that occur as a result of unplanned exposure to radiation, such as might occur from the actions of terrorists, or from accidents.
In the event of a radiological exposure incident, such as the detonation of a radiological dispersion device (RDD) in a terrorist attack or accidental exposures to sources of ionizing radiation, it is advantageous to use multiple methods to assess the dosimetry of individuals exposed to this radiation (4). These methods should include a physical assessment of the dosimetry at the exposure site to, 1) identify the type of radiation (e.g., gamma rays, neutrons or radioisotopes), 2) evaluate the distribution of radioisotopes and/or radioactivity at the site, and 3) determine the location of exposed individuals to the source of radiation. For individuals affected by the radiological incident, the monitoring of their clinical signs and symptoms is important for determining whether acute symptoms of radiation sickness are being presented and if immediate medical intervention is required. However, it is recognized that an invaluable aid for the clinical management of exposed individuals is the use of biomarkers that can be readily obtained from the exposed individual and used for assessing dosimetry (4,9). Biomarkers that are most useful to the physician are those produced or expressed within minutes to hours following exposure. With the dosimetry provided through these early phase biomarker measurements, the physician can better assess the clinical signs that are presented by an exposed individual and better determine the need and course of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care radiation therapy | No Intervention | Standard of care given for treatment of cancer. Subjects receiving incidental radiation dose to fingernails. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care given for treatment of cancer | Radiation | Subjects receiving a known dose of radiation during Total Body Irradiation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Dose of Radiation Received by Fingernails | The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR). | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the Range of Background Signal Measured by the EPR Device. | 2.5 years |
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Inclusion Criteria:
Arm 1:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Swarts, PhD | Department of Radiation Oncology, University of Rochester Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Subjects Receiving Incidental Radiation Dose to Fingernails. | Subjects receiving incidental radiation dose to fingernails. Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1Subjects Receiving Incidental Radiation Dose to Fingernails. | Subjects receiving incidental radiation dose to fingernails. Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Dose of Radiation Received by Fingernails | The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR). | The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available. | Posted | 2.5 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Receiving Incidental Radiation Dose to Fingernails. | Subjects receiving incidental radiation dose to fingernails. Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Swarts | University of Rochester Medical Center | 5852755623 | christine_huggins@urmc.rochester.edu |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units |
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| Counts |
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| Participants |
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| Secondary | Determination of the Range of Background Signal Measured by the EPR Device. | The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available. | Posted | 2.5 years |
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