ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618000627257

Ethics application status

Approved

Date submitted

18/01/2018

Date registered

20/04/2018

Date last updated

7/01/2020

Date data sharing statement initially provided

18/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

National Dermatology Radiation Oncology Registry: A multi-site Registry recording clinical observations of patients referred for radiotherapy for the management of skin cancers and inflammatory skin diseases

Scientific title

Secondary ID [1]

NIl

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Skin Cancer including BCC, SCC, IEC, Melanoma and other skin tumours

Inflammatory and non inflammatory skin conditions

Condition category

Condition code

Cancer

Malignant melanoma

Cancer

Non melanoma skin cancer

Skin

Dermatological conditions

Skin

Other skin conditions

Inflammatory and Immune System

Other inflammatory or immune system disorders

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Years

Description of intervention(s) / exposure

The Registry is a human research registry that collects and collate information from patients referred for radiotherapy for the management of melanoma, and non melanoma skin cancers and difficult to manage inflammatory skin diseases. Non-interventionalist observations of radiotherapy treatment for skin cancer and other inflammatory skin conditions for patients referred by a Dermatologist. The Registry will be recording demographics, relevant medical history, lesion assessment, treatment outcomes and follow up. Participant follow up is as follows:
- Immediately after and 3 months post treatment with Treating Radiation Oncologist
= 6, 12, 18, 24 months post treatment and yearly there after with Referring dermatologist as per their usual standard of care.

There is an option to record data post the two year period if as part of usual routine of care. This Registry data will be used in future studies to prospectively assess treatment outcomes for patients undergoing radiotherapy for skin their skin.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To evaluate the presentation of patients with skin cancers and inflammatory skin diseases managed in routine clinical practice by complete full skin examination and their progress course of radiotherapy.

The collected data variables are grouped in the following categories:
Demographic
Medical History
Lesion Assessment
Treatment Plan
Treatment Outcomes
Followup of clinical, cosmetic and toxicity.
Quality of Life

A full list of data points is available as an attachment to the ANZCTR trial record.

The Registry data is collected by clinician assessments, review of medical records, and patient reported outcome measures.

Timepoint [1]

At routine clinic visits till loss to follow up,
Participant follow up is as follows:
- Immediately after and 3 months post treatment with Treating Radiation Oncologist
= 6, 12, 18, 24 months post treatment and yearly there after with Referring dermatologist as per their usual standard of care.

Primary outcome [2]

To evaluate the radiotherapy treatment outcomes of clearance of tumours measured by percentage decrease in tumour size and load post radiotherapy treatments by clinicians assessments for skin cancers.

Timepoint [2]

Primary time points include: Baseline, and 5 years post treatment. and is also assessed at the follow up visits: Immediately after treatment is completed, 3 month, 6 month, 12 month 18 month and yearly thereafter in line with usual treatment regime.

Primary outcome [3]

To evaluate the severity and toxicities resulting in radiotherapy treatment if present by specialist assessments.

Timepoint [3]

primary time-point is 3 months post completion of radiotherapy and is also assessed at all follow up visits: Immediately after treatment is completed, 3 month, 6 month, 12 month 18 month and yearly thereafter in line with usual treatment regime.

Secondary outcome [1]

To evaluate the management variables of toxicities resulting in radiotherapy treatment if present by specialist assessments.

Timepoint [1]

Eligibility

Key inclusion criteria

1. over 18 years of age
2. diagnosed with a treatable skin cancer or inflammatory skin condition by a dermatologist
3. elligible to be treated using radiotherapy
4. patient has voluntarily signed and dated informed consent/patient authorisation form

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. patients who do not consent to their involvement in the registry

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

NIl

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/05/2018

Actual

17/05/2018

Date of last participant enrolment

Anticipated

30/11/2027

Actual

Date of last data collection

Anticipated

30/11/2037

Actual

Sample size

Target

10000

Accrual to date

209

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Genesis Cancer Care

Address [1]

Building 1 & 11 The Mill, 41-42 Bourke Road
Alexandria
Sydney
NSW 2015

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Genesis Cancer Care and Specialist Connect Services

Address

Genesis Cancer Care
Building 1 & 11 The Mill, 41-42 Bourke Road
Alexandria
Sydney
NSW 2015

Specialist Connect Services
Suite 18, level 1, 250 Ipswich Road
Woolloongabba QLD 4102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Ethics Committee

Ethics committee address [1]

129 Glen Osmond Road
Eastwood 
SA 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

31/05/2017

Ethics approval number [1]

2017-04-288-A-2

Summary

Brief summary

The National Dermatology Radiation Oncology Registry (NDROR) is a human research Registry that collects and collates information from patients referred for radiotherapy for the management of non-melanoma and melanoma skin cancer and difficult to manage inflammatory skin diseases. 

Who is it for?
Patients aged 18 years or above will be recruited based on referral from their current treating dermatologist to a Genesis Cancer Care (GCC) Radiation Oncologist once diagnosed with a lesion or condition deemed treatable with radiotherapy. 

Study details
Data may be collected from eligible patients retrospectively regarding their previous relevant medical history, and prospectively, including treatment schedule and treatment outcomes of their radiotherapy treatment. Upon agreeing to participate in the NDROR, the referring dermatologist (RD) will send information to the Treating Radiation Oncologist (TRO). Previous relevant medical history as well as current treatment plans will be imported by both RD and TROs into the data Registry called the Skin and Radiotherapy Online Secure Platform (OSP).

The intended outcome of this Registry is to ultimately assess the safety, tolerability and outcomes of treatment. Although treatment of skin cancer and inflammatory skin conditions with radiotherapy is currently used, limited practical evidence into the safety, tolerability and outcomes based evidence has been established in Australia. This Registry will be the first of its kind in Australia and will provide a basis for a number of research publications assessing these outcomes.

Trial website

NA

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/374328-NDROR Master Data Point List.docx (Supplementary information)

Contacts

Principal investigator

Name

Dr Lynda Spelman

Address

Specialist Connect Services
Suite 18, Level 1
250 Ipswich Rd
Woolloongabba
Brisbane QLD 4102

Country

Australia

Phone

+61 7 30391300

Fax

Info@sc-services.com.au

Contact person for public queries

Name

Lynda Spelman

Address

Specialist Connect Services
Suite 18, Level 1
250 Ipswich Rd
Woolloongabba
Brisbane QLD 4102

Country

Australia

Phone

+61 7 3039 1300

Fax

info@sc-services.com.au

Contact person for scientific queries

Name

Lynda Spelman

Address

Specialist Connect Services
Suite 18, Level 1
250 Ipswich Rd
Woolloongabba
Brisbane QLD 4102

Country

Australia

Phone

+ 61 7 3039 1300

Fax

info@sc-services.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified data may be shared to Authors who wish to report on outcomes of the NDROR through a formal request process. The requested de-identified data points that are relevant to the primary and secondary aims of the proposed study will be made available to the Authors once approval by the NDROR Research Committee has been granted.

When will data be available (start and end dates)?

Data will be made available upon request for the duration of the approved study purposes. This will be negotiated on a case-by-case basis depending on study design requirements.
Start date: July 2019
No end date determined'

Available to whom?

Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of the NDROR Research Committee.

Available for what types of analyses?

Any purpose, only to achieve the aims in the approved proposal, qualitative or quantitative registry data is collected and available for analysis.

How or where can data be obtained?

Access subject to approvals by The NDROR Research Committee (please email info@sc-services.com.au for details of the submission process).

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Preliminary efficacy and safety analysis: 12-month results in 83 patients using a novel approach of widefield radiation therapy for extensive skin field cancerization with or without keratinocyte cancers.	2022	https://dx.doi.org/10.1080/09546634.2022.2067814
Embase	Radiotherapy, Utilizing Volumetric Modulated Arc Therapy, for Extensive Skin Field Cancerization: A Retrospective Case Series Assessing Efficacy, Safety, and Cosmetic Outcomes at 12 Months after Treatment.	2022	https://dx.doi.org/10.1159/000521067
Embase	Response to: Radiation Oncology Viewpoint: Wide-field radiation therapy for skin cancerisation-Have we forgotten what we learned?.	2023	https://dx.doi.org/10.1111/1754-9485.13531
Dimensions AI	Efficacy and safety analysis: 24-month outcomes from a prospective cohort of 106 fields treated with widefield radiation therapy for extensive skin field cancerization, with or without keratinocyte cancers	2023	https://doi.org/10.1002/jvc2.312

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically