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Radiation Biodosimetry in Children Undergoing Total Body Irradiation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Baker, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01337648
First received: March 2, 2011
Last updated: June 21, 2016
Last verified: June 2016
  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 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: March 2, 2011
Last Updated: June 21, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Fecal biomarkers
Radiation biodosimetry
Total-body irradiation (TBI)
Hematopoietic stem cell transplantation
Gene expression profiles
Fecal metabolites

ClinicalTrials.gov processed this record on December 05, 2016