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NCT04681456 Clinical Trial

Skin Cancer Oncology Radiation Evidence Registry

Non-melanoma Skin Cancer Clinical Trial

— SCORER  

Official title:
Skin Cancer Oncology Radiation Evidence Registry

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04681456
Other study ID # GCUSA-2020-03
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 15, 2021
Est. completion date May 6, 2021

Study information
Verified date December 2020
Source GenesisCare USA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 350
Est. completion date May 6, 2021
Est. primary completion date May 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• There is no medical intervention for the purposes of this Registry.
There is no medical intervention for the purposes of this Registry.

Locations
Country Name City State
United States GenesisCare USA Fort Myers Florida

Sponsors (1)
Lead Sponsor Collaborator
GenesisCare USA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. To assess participant safety following treatment of non-melanoma skin cancers with radiotherapy. 5 years
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