Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-31 @ 2:48 AM
Study NCT ID:
NCT04681456
Status:
TERMINATED
Last Update Posted:
2021-05-14
First Post:
2020-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Cancer Oncology Radiation Evidence Registry
Sponsor:
GenesisCare USA
Organization:
Study Overview
Official Title:
Skin Cancer Oncology Radiation Evidence Registry
Status:
TERMINATED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped in order to reconfigure it as a PhaseII/III study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCORER
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: