RADTOX: Measuring Radiation Toxicity Using Circulating DNA (RADTOX)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||RADTOX: Measuring Radiation Toxicity Using Circulating DNA|
- Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared to CTCAE v4.0 [ Time Frame: 9 Months ]
- Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared pain scores [ Time Frame: 9 Months ]
- Free circulating DNA will be measured in patients undergoing radiation for prostate cancer as a toxicity biomarker compared and visual analog scales of toxicity [ Time Frame: 9 Months ]
Biospecimen Retention: Samples With DNA
|Actual Study Start Date:||October 2016|
|Estimated Study Completion Date:||April 2018|
|Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Evaluate toxicity biomarkers
Investigators will determine if measurement of circulating DNA from tumor and normal tissues shortly after RT provides an early and quantitative measure of risk of radiation-related complications. It will be necessary to collect blood specimens prior to and during the first week of radiation therapy.
Other: Plasma Blood collection
Plasma blood collection is collected at specific intervals prior to and during radiation treatment.
Other Name: Plasma/Blood Collection
Currently, a patient's risk for toxicity is based almost exclusively on population statistics. Radiation (and chemotherapy) dose are based on phase I data and not on the individual's specific genetics or hidden predispositions. RadTox measures cell damage within 24 hours of radiation exposure and should help identify patients at higher risk for radiation complications. This should allow physicians to adjust radiation field size and dose to minimize long-term toxicity.
Patients undergoing radiation treatment for stage I to III prostate cancer, using protons or X-rays, either as primary treatment or consolidation after prostatectomy (positive margins or prostate-specific assay [PSA]-related indications) will be eligible. Hormone treatment will be allowed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02941029
|Contact: John Lybarger, MPH, CCRC||352-265-0680 ext 87829||LYBARJ@shands.ufl.edu|
|Contact: Andrew Chadwick, MPH, CCRP||352-265-0680 ext firstname.lastname@example.org|
|United States, Florida|
|University of Florida Health||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: John M Lybarger, MPH 352-265-0680 ext 87829 email@example.com|
|Contact: Andrew Chadwick 352-265-0680 ext 87820 firstname.lastname@example.org|
|Principal Investigator: Randall Henderson, MD|
|University of Florida Health Proton Therapy Institute||Recruiting|
|Jacksonville, Florida, United States, 32206|
|Contact: David Monticalvo, MPH 904-588-1512 email@example.com|
|Principal Investigator:||Randal Henderson, MD, MBA||Clinical Professor|