Studying Radiation Doses in Patients Undergoing Stem Cell Transplant Treated With Total-Body Irradiation
Recruitment status was Recruiting
RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about radiation doses and predict how patients will respond to treatment.
PURPOSE: This research study is evaluating radiation doses in patients undergoing stem cell transplant treated with total-body irradiation.
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Genetic: RNA analysis
Genetic: cytogenetic analysis
Genetic: gene expression analysis
Genetic: protein expression analysis
|Official Title:||Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)|
- Validation and refinement of three methods of rapid high throughput radiation biodosimetry [ Designated as safety issue: No ]
- Mechanistic insight into potentially different responses to radiation between mice and humans, and between ex vivo and in vivo irradiation [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- To validate and refine three methods of rapid high throughput radiation biodosimetry using peripheral blood and urine from patients undergoing total-body irradiation preceding hematopoietic stem cell transplantation, including miniaturization and automation of cytogenetic and immunofluorescence assays, development and testing of gene expression profiles for use as biodosimeters and their incorporation into a self-contained test cassette, and profiling urinary metabolites that are specific for radiation exposure and dose.
- To gain mechanistic insight into potentially different responses to radiation between mice and humans, and between ex vivo and in vivo irradiation.
OUTLINE: This is a multicenter study.
Patients undergo blood and optional urine sample collection before the start of the first total-body irradiation (TBI) treatment, 4-8 hours after the first TBI (but before the second), and 24 hours after the first TBI treatment. Samples are analyzed for RNA extraction and subsequent microarray analysis. Some patients may have additional blood samples collected prior to TBI for validation studies, at the discretion of the investigator. Samples are analyzed for micronucleus formation and γH2AX focus formation to assess whether blood irradiation in vivo demonstrates a different biological response to blood irradiated ex vivo. An additional blood sample is obtained at the first time point (prior to TBI irradiation) and stored for future correlative studies. Samples are analyzed using cytogenetic, protein, metabolic, and gene expression assays.
Patient medical records are obtained and reviewed for age, gender, race, ethnicity, diagnosis, disease status, cytogenetics, HLA typing data, prior treatment (chemotherapy and radiotherapy), pre-transplant disease-specific data such as blood counts, metabolic profiles, co-existing disease at the time of transplant, history of infection exposure prior to transplant, former and active medical problems (with prior and active therapies, both prescribed and over-the-counter, including herbals, vitamins and dietary supplements), functional status, organ function prior to transplant, special or unusual dietary history, history of tobacco, alcohol or illicit drug use, carcinogen/toxin/teratogen/mutagen exposure history, and infectious disease markers for hepatitis B and C, syphilis, HIV, CMV, HTLV I/II.
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Suzanne Wolden, MD 212-639-5148 firstname.lastname@example.org|
|Principal Investigator:||Suzanne Wolden, MD||Memorial Sloan-Kettering Cancer Center|