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Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01337648
Enrollment
2
Registered
2011-04-19
Start date
2010-11-30
Completion date
2015-09-30
Last updated
2016-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplant, Total-body Irradiation

Keywords

Fecal biomarkers, Radiation biodosimetry, Total-body irradiation (TBI), Hematopoietic stem cell transplantation, Gene expression profiles, Fecal metabolites

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.

Interventions

None listed

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No

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).

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026