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Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Completed
Conditions
Hematopoietic Stem Cell Transplant
Total-body Irradiation
Registration Number
NCT01337648
Lead Sponsor
Medical College of Wisconsin
Brief Summary

The purpose of this study is to develop fecal tests that will determine the extent of radiation exposure in patients undergoing radiation treatment for cancer. This project will determine whether fecal biomarkers can be used to diagnose exposure to radiation.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2
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).
Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To describe changes in gene expression associated with exposure to radiationprior to TBI treatment (baseline) and up to 2 weeks following the last dose of TBI

Changes in gene expression will be measured as abundance of RNA levels relative to the weight of feces

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Children's Hospital of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

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