Expired Study
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Milwaukee, Wisconsin 53226


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.

Study summary:

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).

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Official Title:

Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Overall Status:


Study Phase:




Minimum Age:

2 Years

Maximum Age:

21 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical College of Wisconsin

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Case-Only, Time Perspective:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:John Baker, MD
Principal Investigator
Medical College of Wisconsin

Study Dates

Start Date:November 2010
Completion Date:September 2015
Completion Type:Actual
Primary Completion Date:September 2015
Primary Completion Type:Actual
Verification Date:June 2016
Last Changed Date:June 21, 2016
First Received Date:March 2, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:To describe changes in gene expression associated with exposure to radiation
Time Frame:prior to TBI treatment (baseline) and up to 2 weeks following the last dose of TBI
Safety Issues:False
Description:Changes in gene expression will be measured as abundance of RNA levels relative to the weight of feces

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:TBI prior to stem cell transplantation

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical College of Wisconsin

Samples and Retentions

Sample Retention:Samples With DNA
Description: Stool
Study Population: Patients undergoing Total Body Irradiation (TBI) preceding hematopoietic stem cell transplantation.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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