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.

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Key information

Conditions

Total-body Irradiation Hematopoietic Stem Cell Transplant

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Apr 19, 2011
Registry last updated: Jun 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed