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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Recruitment Status : Withdrawn (PI decision)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

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.

Condition or disease Intervention/treatment
Solid Tumors Cancer Radiation: Radiation Therapy

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)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Patient Registry for Prospective Research on Evolving Radiation Oncology Techniques and Quality
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : December 2030

Group/Cohort Intervention/treatment
Radiation Therapy
Participants receiving one of the 11 listed therapy modalities.
Radiation: Radiation Therapy
targeted radiation treatment




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
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

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): NCT02368106


Locations
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United States, Maryland
Ummc Msgcc
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: William Regine, MD UMMC MSGCC Department of Radiation Oncology
Additional Information:

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Responsible Party: Department of Radiation Oncology, Principle Investigator, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02368106    
Other Study ID Numbers: HP-00060494
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Department of Radiation Oncology, University of Maryland, Baltimore:
patient registry
radiation oncology
technology assessment
Additional relevant MeSH terms:
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Neoplasms