RADTOX: Measuring Radiation Toxicity Using Circulating DNA (RADTOX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02941029|
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : August 29, 2019
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: 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.
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|Official Title:||RADTOX: Measuring Radiation Toxicity Using Circulating DNA|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||July 2017|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941029
|United States, Florida|
|University of Florida Health|
|Gainesville, Florida, United States, 32610|
|University of Florida Health Proton Therapy Institute|
|Jacksonville, Florida, United States, 32206|
|Principal Investigator:||Randal Henderson, MD, MBA||clinical professor|