Skin Cancer Oncology Radiation Evidence Registry (SCORER)

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.

Study Overview

• Status: Terminated
• Conditions: Non-melanoma Skin Cancer
• Intervention / Treatment: Behavioral: There is no medical intervention for the purposes of this Registry.

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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33907
      • GenesisCare USA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited based on their potential eligibility to receive VMAT widefield radiotherapy treatment of their NMSC. The RO will assess if the condition is suitable for VMAT treatment, and if so, will discuss the Registry with the participant.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GenesisCare USA
• Investigators: Principal Investigator: Constantine Mantz, MD, GenesisCare USA

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: GCUSA-2020-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All other researchers belong to the same organization and could potentially have access to all data gathered.
• IPD Sharing Time Frame: 2021 or 2022
• IPD Sharing Access Criteria: Data will be stored on secured servers of the sponsoring organization and will be password protected with limited access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No