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Radiation Biodosimetry in Children Undergoing Total Body Irradiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01337648
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : June 22, 2016
Information provided by (Responsible Party):
John Baker, 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.

Condition or disease
Total-body Irradiation Hematopoietic Stem Cell Transplant

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.

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Radiation Biodosimetry in Children Undergoing Total Body Irradiation
Study Start Date : November 2010
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

TBI prior to stem cell transplantation

Primary Outcome Measures :
  1. 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 ]
    Changes in gene expression will be measured as abundance of RNA levels relative to the weight of feces

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing Total Body Irradiation (TBI) preceding hematopoietic stem cell transplantation.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01337648

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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
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Principal Investigator: John Baker, MD Medical College of Wisconsin
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Responsible Party: John Baker, Professor of Surgery/Cardiothoracic/Research, Medical College of Wisconsin Identifier: NCT01337648    
Other Study ID Numbers: RadBio-10/191
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Keywords provided by John Baker, Medical College of Wisconsin:
Fecal biomarkers
Radiation biodosimetry
Total-body irradiation (TBI)
Hematopoietic stem cell transplantation
Gene expression profiles
Fecal metabolites