Genotoxicity Assessment for Patients Undergoing Radiation Treatment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Genotoxicity Assessment for Patients Receiving Large Field Irradiation|
- Measure the Change in MN-RET in the blood [ Time Frame: Baseline and 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||October 2018|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Correlative studies: analysis of RT effect on genotoxicity by assessing cytogenetic changes (dicentrics), micronucleated lymphocytes (MN-lymph), and micronucleated reticulocytes (MN-RET) using peripheral blood of patients receiving radiation.
i) document the kinetics by which radiation-induced MN-RET enter the peripheral blood stream.
ii) benchmark the MN-RET endpoint against current gold-standard biodosimetry endpoints—dicentrics and MN-lymphocytes.
iii) measure inter-individual variation in baseline and radiation-induced MN-RET frequencies.
iv) in collaboration with several FCM-equipped laboratories, evaluate the transferability of the human MN-RET scoring assay.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167427
|Contact: Therese Smudzin, BSemail@example.com|
|Contact: Yuhchyau Chen, MD, Ph.Dfirstname.lastname@example.org|
|United States, New York|
|University of Rochester, Dept. Radiation Oncology||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Yuhchayau Chen, MD, Ph.D.|
|Principal Investigator: Yuhchyau Chen, MD, Ph.D|
|Principal Investigator:||Yuhchyau Chen, MD, Ph.D||Universtiy of Rochester, Dept of Radiation Oncology|