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Prospective Patient Registry for Radiation Oncology Techniques and Quality (GCC 1490)

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: NCT02368106
Recruitment Status : Withdrawn (PI decision)
First Posted : February 20, 2015
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland, Baltimore

Tracking Information
First Submitted Date January 20, 2015
First Posted Date February 20, 2015
Last Update Posted Date September 12, 2019
Estimated Study Start Date February 2018
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2015)
Numbers of patients experiencing toxicities/adverse events both during and at follow-up after radiation therapy with any of 11 therapeutic modalities. [ Time Frame: 5 years ]
Records will be assessed to identify per-patient numbers and grades of toxicities and adverse events resulting from radiation treatment for oncologic conditions as graded by treating physicians according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) during the period of radiation treatment and at each regularly scheduled clinical follow-up appointment, for each of the 11 therapeutic modalities listed as interventions.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 13, 2015)
  • Numbers of patients with different initial diagnoses associated with short- and long-term toxicities with specific radiation treatments. [ Time Frame: 5 years ]
    Records will be assessed to identify numbers of patients with specific initial diagnoses (from approximately 100 International Statistical Classification of Diseases and Related Health Problems [ICD 9] malignant neoplasm diagnoses) who experience short- and long-term toxicities after any of the 11 therapeutic modalities listed as interventions.
  • Numbers of men and women who experience short- and long-term toxicities after specific radiation treatments. [ Time Frame: 5 years ]
    Records will be assessed to identify numbers of men and women who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
  • Age differences in short- and long-term toxicities associated with specific radiation treatment modalities. [ Time Frame: 5 years ]
    Records will be assessed to identify numbers of men and women between the ages of 18-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, and ≥90 years who experience CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
  • Patient income differences in short- and long-term toxicities associated with specific radiation treatment modalities. [ Time Frame: 5 years ]
    Records will be assessed for income (by patient home zip code per U.S. Internal Revenue statistics available at http://www.irs.gov/uac/SOI-Tax-Stats-Individual-Income-Tax-Statistics-ZIP-Code-Data-(SOI)) to identify income level differences and per-patient numbers/ types of CTCAE-defined levels of toxicity during and after radiation treatment with any of the 11 therapeutic modalities listed as interventions.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Patient Registry for Radiation Oncology Techniques and Quality
Official Title Patient Registry for Prospective Research on Evolving Radiation Oncology Techniques and Quality
Brief Summary This study will create a patient data registry to collect and analyze information on technology usage and outcomes among patients receiving a broad range of relatively new radiation treatments that have become standards of care in our practice. Review of this information will serve as a basis for development of better patient management plans, to inform decisions about acquisition of new technologies, to provide information about quality in our care delivery, and to create a database that will securely warehouse ongoing information about what treatments the patients we serve need most and the challenges they face in the treatment process. The information gathered is likely to not only improve our services at the University of Maryland and its community sites but to advance medical science and enhance the quality of care for cancer patients.
Detailed Description

The purpose of this study is to create a robust and long-term patient data registry containing limited demographic, diagnostic, treatment, and follow-up data on patients at the study sites undergoing one or more of the following radiation treatments/technologies:

Brachytherapy, including High-Dose-Rate and Low-Dose-Rate Techniques/ GammaPod Therapy/ GRID Treatment/ Image-Guided Radiation Therapy/ Intensity-Modulated Radiation Therapy and Intensity-Modulated Arc Therapy/ MammoSite and SAVI Applicator/ Photodynamic Therapy/ Proton Therapy/ SIR Spheres and Radiolabeled Microsphere Therapy/ Stereotactic Radiosurgery and Stereotactic Body Radiotherapy/ Thermal Therapy (Hyperthermia)

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinic
Condition
  • Solid Tumors
  • Cancer
Intervention Radiation: Radiation Therapy
targeted radiation treatment
Study Groups/Cohorts Radiation Therapy
Participants receiving one of the 11 listed therapy modalities.
Intervention: Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: March 12, 2018)
0
Original Estimated Enrollment
 (submitted: February 13, 2015)
5000
Estimated Study Completion Date December 2030
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who are 18 years old or older and scheduled to undergo any of the listed radiation treatment technologies at the University of Maryland Medical Center or one of its community sites as included in this protocol provided s/he consents to participate.

Exclusion Criteria:

  • Patients who are incarcerated or in legal custody are not eligible for this study.
  • Patients who are younger than 18 years, are cognitively impaired, or are otherwise unable to provide informed consent.
  • Patients who are pregnant
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02368106
Other Study ID Numbers HP-00060494
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Department of Radiation Oncology, University of Maryland, Baltimore
Study Sponsor University of Maryland, Baltimore
Collaborators Not Provided
Investigators
Principal Investigator: William Regine, MD UMMC MSGCC Department of Radiation Oncology
PRS Account University of Maryland, Baltimore
Verification Date September 2019