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NCT01337648 Clinical Trial

Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Hematopoietic Stem Cell Transplant Clinical Trial

Official title:
Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01337648
Other study ID # RadBio-10/191
Secondary ID
Status Completed
Phase N/A
First received March 2, 2011
Last updated June 21, 2016
Start date November 2010
Est. completion date September 2015

Study information
Verified date June 2016
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 2
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 21 Years
Eligibility 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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To describe changes in gene expression associated with exposure to radiation Changes in gene expression will be measured as abundance of RNA levels relative to the weight of feces prior to TBI treatment (baseline) and up to 2 weeks following the last dose of TBI No
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