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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581958
• Other study ID #: 07-158
• Status: Completed
• Start date: November 2007
• Est. completion date: October 31, 2018

Study information

• Verified date: November 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00899886

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Georgetown University, National Institute of Standards and Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays.	The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.	3 years

External Links

•   Memorial Sloan Kettering Web Site