Radiation Biodosimetry in Children Undergoing Total Body Irradiation

NCT ID: NCT01337648

Last Updated: 2016-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Total-body Irradiation Hematopoietic Stem Cell Transplant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TBI prior to stem cell transplantation

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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John Baker

Professor of Surgery/Cardiothoracic/Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Baker, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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RadBio-10/191

Identifier Type: -

Identifier Source: org_study_id

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