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


N/A
4 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

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


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.


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).

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To develop, validate and refine high-throughput platforms for radiation biodosimetry using cytogenetic, protein, metabolomic and gene expression assays.

Outcome Time Frame:

conclusion of the study

Safety Issue:

Yes

Principal Investigator

Christopher Barker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-158

NCT ID:

NCT00581958

Start Date:

November 2007

Completion Date:

December 2013

Related Keywords:

  • Cancer
  • total body irradiation
  • Cancer
  • Hematopoietic System

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021