Skin Cancer Oncology Radiation Evidence Registry

NCT04681456 | Terminated

• 1 other identifier: GCUSA-2020-03
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

There is no medical intervention for the purposes of this Registry. BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GenesisCare USA: lead

Study Sites (1)

GenesisCare USA

Fort Myers, Florida, 33907, United States

Location

Study Officials

• Constantine Mantz, MD

  GenesisCare USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 23, 2020
• Study Start: February 15, 2021
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: May 14, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2021 or 2022
• Access Criteria: Data will be stored on secured servers of the sponsoring organization and will be password protected with limited access.

Locations

US (1)