Prospective Patient Registry for Radiation Oncology Techniques and Quality

NCT02368106 | Withdrawn DMC

• 1 other identifier: HP-00060494
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors; Cancer

Keywords

patient registry; radiation oncology; technology assessment

Outcome Measures

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.

  5 years

Secondary Outcomes (4)

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

  5 years

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

  5 years

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

  5 years

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

  5 years

Study Arms (1)

Radiation Therapy

Participants receiving one of the 11 listed therapy modalities.

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

targeted radiation treatment

Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Ummc Msgcc

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• William Regine, MD

  UMMC MSGCC Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: February 20, 2015
• Study Start: February 1, 2018
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (1)