Clinical trial NCT02368106: Prospective Patient Registry for Radiation Oncology Techniques and Quality
Official title: Patient Registry for Prospective Research on Evolving Radiation Oncology Techniques and Quality
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Solid Tumors
Cancer
Keywords: patient registry
radiation oncology
technology assessment
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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)

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

Primary outcomes:
measure: Numbers of patients experiencing toxicities/adverse events both during and at follow-up after radiation therapy with any of 11 therapeutic modalities.
timeFrame: 5 years
Secondary outcomes:
measure: Numbers of patients with different initial diagnoses associated with short- and long-term toxicities with specific radiation treatments.
timeFrame: 5 years
measure: Numbers of men and women who experience short- and long-term toxicities after specific radiation treatments.
timeFrame: 5 years
measure: Age differences in short- and long-term toxicities associated with specific radiation treatment modalities.
timeFrame: 5 years
measure: Patient income differences in short- and long-term toxicities associated with specific radiation treatment modalities.
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Ummc Msgcc
state: Maryland
Study officials:
affiliation: UMMC MSGCC Department of Radiation Oncology
name: William Regine, MD
role: PRINCIPAL_INVESTIGATOR
References: