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

NCT00581958 | Completed

• 1 other identifier: 07-158
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

total body irradiation; Cancer; Hematopoietic System

Outcome Measures

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.

  3 years

Study Arms (1)

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

Blood Samples OTHER

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.

Patients undergoing HSCT

Eligibility Criteria

• Age: 4 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Georgetown University: collaborator
• National Institute of Standards and Technology: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Web Site

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and Urine

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christopher Barker, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: November 1, 2007
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

US (1)