Skin Cancer Oncology Radiation Evidence Registry

NCT ID: NCT04681456

Last Updated: 2021-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-05-06

Brief Summary

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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

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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.

Conditions

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Non-melanoma Skin Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GenesisCare USA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Constantine Mantz, MD

Role: PRINCIPAL_INVESTIGATOR

GenesisCare USA

Locations

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GenesisCare USA

Fort Myers, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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GCUSA-2020-03

Identifier Type: -

Identifier Source: org_study_id

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