Text Size

Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)

This study is currently recruiting participants.
Verified July 2012 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581958
First received: December 21, 2007
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.


Condition Intervention
Cancer
 Other: Blood Samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To develop, validate and refine high-throughput platforms for radiation biodosimetry using cytogenetic, protein, metabolomic and gene expression assays. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Blood Samples
    blood (13 ml; equivalent to less than 1 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.
Detailed Description:

MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients greater than 4 years of age at Memorial Sloan-Kettering Cancer Center
  • Must be undergoing hematopoietic stem cell transplantation (either autologous or allogenic) in conjunction with a conditioning regimen that includes TBI (single or multiple fraction)
  • Functional central venous catheter

Exclusion Criteria:

  • No subjects will be excluded from the proposed research study for demographic reasons. Treatment with growth factors, such as keratinocyte growth factor (KGF), will not be grounds for exclusion.
  • Subjects who will receive radiation therapy within 5 days prior to TBI will be excluded.
  • Subjects who will receive systemic antineoplastic chemotherapy within 7 days prior to TBI not have research bloods collected. Only urine will be collected from these patients.
  • Subjects less than 4 years of age will be excluded because they are not treated with TBI.
  • Based on current knowledge, we will not a priori exclude patients based on disease status (ie, patients in or out of remission will be included in this study), type of disease(ie, chromosomal breakage syndromes), or previous therapies (unless exclusion criteria is met).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581958

Contacts
Contact: Christopher A. Barker, MD 212-639-8168

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Christopher Barker, MD     212-639-8168        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Columbia University
Investigators
Principal Investigator: Christopher Barker, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581958     History of Changes
Other Study ID Numbers: 07-158
Study First Received: December 21, 2007
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
total body irradiation
Cancer
Hematopoietic System

ClinicalTrials.gov processed this record on May 22, 2013