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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Georgetown University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581958
First received: December 21, 2007
Last updated: January 31, 2014
Last verified: January 2014
  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:


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 metabolomic assays. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.


Estimated Enrollment: 253
Study Start Date: November 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients undergoing HSCT
Research subjects will have blood and/or urine sampled at three time points in the Department of Radiation Oncology. Participating patients will have at least a total two samples collected at each time point. The first sampling will occur before the first TBI treatment is given. The second sampling will occur before the second TBI treatment, usually 3 to 8 hours after the first treatment (in the case of multifraction TBI). If a patient is being treated with single fraction TBI, then the second sampling will occur approximately 3-8 hours after the first TBI treatment. The third and final sampling will occur at the next morning blood draw, prior to the fourth TBI treatment (in the case of multifraction TBI), 24 hours after the first TBI treatment.
Other: Blood Samples
blood (approximately two 4 ml; equivalent to less than 2 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.
  • 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
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: 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      
Contact: Marcel VandenBrink, MD, PhD    646-888-2304      
Principal Investigator: Christopher Barker, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Georgetown University
Investigators
Principal Investigator: Christopher Barker, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581958     History of Changes
Obsolete Identifiers: NCT00899886
Other Study ID Numbers: 07-158
Study First Received: December 21, 2007
Last Updated: January 31, 2014
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 July 29, 2014