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Radiation Biodosimetry in Children Undergoing Total Body Irradiation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01337648
First Posted: April 19, 2011
Last Update Posted: June 22, 2016
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.
Information provided by (Responsible Party):
John Baker, Medical College of Wisconsin
March 2, 2011
April 19, 2011
June 22, 2016
November 2010
September 2015   (Final data collection date for 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 ]
Changes in gene expression will be measured as abundance of RNA levels relative to the weight of feces
Same as current
Complete list of historical versions of study NCT01337648 on ClinicalTrials.gov Archive Site
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Radiation Biodosimetry in Children Undergoing Total Body Irradiation
Radiation Biodosimetry in Children Undergoing Total Body Irradiation
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Stool
Non-Probability Sample
Patients undergoing Total Body Irradiation (TBI) preceding hematopoietic stem cell transplantation.
  • Total-body Irradiation
  • Hematopoietic Stem Cell Transplant
Not Provided
TBI prior to stem cell transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
September 2015
September 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
2 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01337648
RadBio-10/191
No
Not Provided
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John Baker, Medical College of Wisconsin
Medical College of Wisconsin
Not Provided
Principal Investigator: John Baker, MD Medical College of Wisconsin
Medical College of Wisconsin
June 2016