Clinical trial · Observational
Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)
NCT00581958CI-TRIAL-00035616completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing HSCT
- description
- 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.
- interventionNames
- Other: Blood Samples
Primary outcomes (1)
- measure
- To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays.
- timeFrame
- 3 years
- description
- The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.