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Radiation Biodosimetry in Children Undergoing Total Body Irradiation


N/A
2 Years
21 Years
Open (Enrolling)
Both
Total-body Irradiation, Hematopoietic Stem Cell Transplant

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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 WisconsinMilwaukee, Wisconsin  53201