A Study of Gene Expression Biomarkers and Bioassay for Radiation Biodosimetry using Human Blood Irradiation Experiments to Study Gene Expression Changes following Radiation Exposure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Sponsor Protocol Number: 12-002563
About this study
The goal of this study is to investigate gene expression changes in blood (biomarkers) after a person is exposed to radiation. The gene biomarkers identified and selected from data collected in this study will allow healthcare personnel to estimate the level of radiation exposure in an individual as demonstrated by the changes in the levels of these biomarkers. In case of a radiological event, it is beneficial to determine the amount of radiation absorbed, together with other diagnostic tools, to provide important information for medical treatment of the victim. This would be extremely helpful for emergency planning and response. Data from this study may be used to help the development of an experimental diagnostic system that measures gene expression changes rapidly from a small sample of blood.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients who receive TBI for bone marrow transplant or radiation that encompasses 7% or more of the total bone marrow distribution.
- Male and female adult patients
- Between 18 - 90 years old
Exclusion Criteria:
- Concurrent chemotherapy or chemotherapy within 30 days of radiation study
- Pregnant females
- Any previous therapeutic irradiation given within 30 days of study
More information
Publications
Publications are currently not available