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RADTOX: Measuring Radiation Toxicity Using Circulating DNA (RADTOX)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02941029
First Posted: October 21, 2016
Last Update Posted: September 26, 2017
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.
Collaborators:
DiaCarta Inc.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Florida
  Purpose
This research study is being done to develop a new test to identify prostate cancer patients at highest risk of radiotherapy-related complications. This research study would allow monitoring of total tissue damage within 24 hours of radiation exposure in blood samples that could give an initial result within a few days that would help clinicians make treatment decisions. Detection of unusual tissue damage at this early time, well before symptoms occur, could allow doctors to tailor interventions that could include patient therapies that would reduce or prevent the problems that occur due to treatment of their cancer.

Condition Intervention
Prostate Cancer Other: Plasma Blood collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: RADTOX: Measuring Radiation Toxicity Using Circulating DNA

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
collection of plasma

Enrollment: 70
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)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients with undergoing radiation therapy for prostate cancer
Criteria

Inclusion Criteria:

  • Consent to participate in the study and a signed and dated an institutional review board (IRB)-approved consent form conforming to federal and institutional guidelines.
  • ≥ 18 years of age.
  • Patients must have an Eastern Cooperative Oncology Group (An ECOG) performance status of 0 or 1.
  • A diagnosis of adenocarcinoma of the prostate.
  • Not yet begun definitive therapy with chemotherapy or radiation but may have hormones or surgery.
  • Clinically stage I to III tumors.

Exclusion Criteria:

  • Metastatic disease.
  • A history of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval.
  • Active inflammatory bowel disease (i.e., patients requiring current medical interventions or who are symptomatic).
  • Prior pelvic radiation therapy for any reason.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the principal investigator (PI), would preclude the patient from meeting the study requirements.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Florida
University of Florida Health
Gainesville, Florida, United States, 32610
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
DiaCarta Inc.
National Institutes of Health (NIH)
Investigators
Principal Investigator: Randal Henderson, MD, MBA Clinical Professor
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02941029     History of Changes
Other Study ID Numbers: IRB201601961
261201600063C-0-0-1 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2016
First Posted: October 21, 2016
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared with necessary government agencies, the sponsor, and participating providers and institutions as defined in the informed consent document.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Radiation
Chemotherapy