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WithdrawnNCT02368106GCC 1490Updated Sep 12, 2019

Prospective Patient Registry for Radiation Oncology Techniques and Quality

An observational study in Solid Tumors and Cancer, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by University of Maryland, Baltimore · Observational

Why this study was withdrawn
PI decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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)

02

Conditions studied

  • Solid Tumors
  • Cancer

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Keywords

  • patient registry
  • radiation oncology
  • technology assessment
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

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Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Radiation Therapy

    Participants receiving one of the 11 listed therapy modalities.

    Radiation: Radiation Therapy

Interventions

  • RadiationRadiation Therapy

    targeted radiation treatment

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What researchers measure

Primary outcomes

  1. Numbers of patients experiencing toxicities/adverse events both during and at follow-up after radiation therapy with any of 11 therapeutic modalities.

    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.

    Time frame: 5 years

Secondary outcomes

  1. Numbers of patients with different initial diagnoses associated with short- and long-term toxicities with specific radiation treatments.

    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.

    Time frame: 5 years

  2. Numbers of men and women who experience short- and long-term toxicities after specific radiation treatments.

    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.

    Time frame: 5 years

  3. Age differences in short- and long-term toxicities associated with specific radiation treatment modalities.

    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.

    Time frame: 5 years

  4. Patient income differences in short- and long-term toxicities associated with specific radiation treatment modalities.

    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.

    Time frame: 5 years

07

Study locations

1 site
  • Ummc Msgcc
    Baltimore, Maryland 21201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02368106
Lead sponsor
University of Maryland, Baltimore
Responsible party
Department of Radiation Oncology (Principle Investigator, University of Maryland, Baltimore) — Principal investigator
First posted
Feb 20, 2015
Start date
Feb 2018 (estimated)
Primary completion
Jan 2025 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 12, 2019

Study contacts

William Regine, MD
principal investigator · UMMC MSGCC Department of Radiation Oncology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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