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CompletedNCT00581958Updated Nov 5, 2018

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

An observational study in Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 4 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-11-05.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
198
Ages
4 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cancer

Keywords

  • total body irradiation
  • Cancer
  • Hematopoietic System
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In context

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Potential research subjects will be identified by the primary Radiation Oncologist whom the patient is referred to by the Adult or Pediatric Bone Marrow Transplant Service.

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
198 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

Interventions

  • OtherBlood 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

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Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00581958
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Georgetown University, National Institute of Standards and Technology
Responsible party
Sponsor
First posted
Dec 28, 2007
Start date
Nov 2007
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018
Last update
Nov 5, 2018

Study contacts

Christopher Barker, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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