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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
  Purpose
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
Total-body Irradiation Hematopoietic Stem Cell Transplant

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Radiation Biodosimetry in Children Undergoing Total Body Irradiation

Further study details as provided by John Baker, Medical College of Wisconsin:

Primary Outcome Measures:
  • 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
Stool

Enrollment: 2
Study Start Date: November 2010
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
TBI prior to stem cell transplantation

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.
  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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).
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01337648


Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: John Baker, MD Medical College of Wisconsin
  More Information

Responsible Party: John Baker, Professor of Surgery/Cardiothoracic/Research, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01337648     History of Changes
Other Study ID Numbers: RadBio-10/191
First Submitted: March 2, 2011
First Posted: April 19, 2011
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