Skin Cancer Oncology Radiation Evidence Registry

Terminated

• Conditions: Non-melanoma Skin Cancer

• Registration Number: NCT04681456
• Lead Sponsor: GenesisCare USA

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Study Start: 2021-02-15
• Primary Completion: 2021-05-06
• Study Completion: 2021-05-06
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	5 years	To assess participant safety following treatment of non-melanoma skin cancers with radiotherapy.

Trial Locations

Locations (1)

GenesisCare USA; 🇺🇸 Fort Myers, Florida, United States