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Clinical Trials/NCT04681456
NCT04681456
Terminated
Not Applicable

Skin Cancer Oncology Radiation Evidence Registry

GenesisCare USA1 site in 1 country350 target enrollmentFebruary 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-melanoma Skin Cancer
Sponsor
GenesisCare USA
Enrollment
350
Locations
1
Primary Endpoint
Participants will have their responses to radiotherapy after treatment of non-melanoma skin cancer measured and reported as number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

To collect and analyze long term safety and efficacy outcomes of patients undergoing radiotherapy for non-melanoma skin cancer. A target of 400 VMAT-treated sites is set which is estimated to be identified in approximately 350 participants. Participants referred for radiotherapy for the management of non-melanoma skin cancer.

Detailed Description

The Registry will collect information on key clinical indications and patient reported outcomes to assess the safety and efficacy of VMAT radiotherapy. Data that will be collected includes baseline data of demographic, relevant medical history, photographs, treatment schedule, and treatment outcomes. Data may be collected retrospectively in regard to previous relevant medical history, prior treatments and outcomes as well as prospectively, including treatment schedule and treatment outcomes of radiotherapy treatment. The Registry aims to assess the safety and outcomes of treatment for up to 5 years. This Registry will be the first of its kind in the US and will provide a basis for a number of potential research publications. The Registry will also give insights into treatment delivery and potentially facilitate future improvements in patient care.

Registry
clinicaltrials.gov
Start Date
February 15, 2021
End Date
May 6, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
GenesisCare USA
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Over 18 years of age
  • Diagnosed with a treatable non-melanoma skin cancer by referring medical practitioner
  • Eligible to be treated using widefield (\>50cm2) VMAT radiotherapy as determined by RO
  • Patient has provided written informed consent.

Exclusion Criteria

  • ♦ Patients who do not consent to their involvement in the Registry.

Outcomes

Primary Outcomes

Participants will have their responses to radiotherapy after treatment of non-melanoma skin cancer measured and reported as number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Time Frame: 5 years

To assess participant safety following treatment of non-melanoma skin cancers with radiotherapy.

Study Sites (1)

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