Skin Cancer Oncology Radiation Evidence Registry | NCT04681456

Studies
Skin Cancer Oncology Radiation Evidence Registry

NCT04681456

Sponsor

GenesisCare USA

Status

Terminated

Last Update Posted

May 14, 2021Actual

Enrollment

350Actual

Phase

Not provided

Conditions

Non-melanoma Skin Cancer

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was stopped in order to reconfigure it as a PhaseII/III study

Expanded Access Info

Start Date

Feb 15, 2021Actual

Primary Completion Date

May 6, 2021Actual

Completion Date

May 6, 2021Actual

First Submitted Date

Dec 17, 2020

First Submission Date that Met QC Criteria

Dec 22, 2020

First Posted Date

Dec 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2021

Last Update Posted Date

May 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There is no medical intervention for the purposes of this Registry.	Behavioral	There is no medical intervention for the purposes of this Registry.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Constantine Mantz, MD	GenesisCare USA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GenesisCare USA		Fort Myers	Florida	33907	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All other researchers belong to the same organization and could potentially have access to all data gathered.

Types

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.

URL

Not provided