Radiation Biodosimetry in Children Undergoing Total Body Irradiation
2 Years
21 Years
Both
Total-body Irradiation, Hematopoietic Stem Cell Transplant
Trial Information
Radiation Biodosimetry in Children Undergoing Total Body Irradiation
Patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have
feces collected for use in the validation and refinement of new methods for rapid radiation
biodosimetry. The stool samples will be collected before, and at defined times after TBI.
Stool sampling will occur in the same manner that it does during routine patient care during
HSCT.
Inclusion Criteria:
- All races are eligible
- 2 years to 21 years old
- Must be undergoing hematopoietic stem cell transplantation (either autologous or
allogeneic) in conjunction with a conditioning regimen that includes total-body
irradiation (TBI) (single or multiple fraction).
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
To describe changes in gene expression associated with exposure to radiation
Outcome Description:
Changes in gene expression will be measured as abundance of RNA levels relative to the weight of feces
Outcome Time Frame:
prior to TBI treatment (baseline) and up to 2 weeks following the last dose of TBI
Safety Issue:
No
Principal Investigator
John Baker, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical College of Wisconsin
Authority:
United States: Institutional Review Board
Study ID:
RadBio-10/191
NCT ID:
NCT01337648
Start Date:
November 2010
Completion Date:
Related Keywords:
- Total-body Irradiation
- Hematopoietic Stem Cell Transplant
- Fecal biomarkers
- Radiation biodosimetry
- Total-body irradiation (TBI)
- Hematopoietic stem cell transplantation
- Gene expression profiles
- Fecal metabolites
Name | Location |
|---|---|
| Children's Hospital of Wisconsin | Milwaukee, Wisconsin 53201 |
