Radiation Biodosimetry in Children Undergoing Total Body... | NCT01337648

Studies
Radiation Biodosimetry in Children Undergoing Total Body Irradiation

NCT01337648

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Jun 22, 2016Estimated

Enrollment

2Actual

Phase

Not provided

Conditions

Total-body Irradiation
Hematopoietic Stem Cell Transplant

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 2, 2011

First Submission Date that Met QC Criteria

Apr 18, 2011

First Posted Date

Apr 19, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2016

Last Update Posted Date

Jun 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Baker, Professor of Surgery/Cardiothoracic/Research, Medical College of WisconsinPrincipal Investigator

Lead Sponsor

Medical College of WisconsinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2Actual

Label	Type	Description	Intervention Names
TBI prior to stem cell transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To describe changes in gene expression associated with exposure to radiation	Changes in gene expression will be measured as abundance of RNA levels relative to the weight of feces	prior to TBI treatment (baseline) and up to 2 weeks following the last dose of TBI

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Patients undergoing Total Body Irradiation (TBI) preceding hematopoietic stem cell transplantation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Baker, MD	Medical College of Wisconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Wisconsin		Milwaukee	Wisconsin	53226	United States