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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
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
Secondary ID [1] 293818 0
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 306240 0
Inflammatory and non inflammatory skin conditions 306241 0
Condition category
Condition code
Cancer 305339 305339 0 0
Malignant melanoma
Cancer 306346 306346 0 0
Non melanoma skin cancer
Skin 306347 306347 0 0
Dermatological conditions
Skin 306348 306348 0 0
Other skin conditions
Inflammatory and Immune System 306349 306349 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
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] 300074 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304491 0
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] 304491 0
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] 305362 0
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] 305362 0
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] 305363 0
To evaluate the severity and toxicities resulting in radiotherapy treatment if present by specialist assessments.
Timepoint [3] 305363 0
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] 342126 0
To evaluate the management variables of toxicities resulting in radiotherapy treatment if present by specialist assessments.
Timepoint [1] 342126 0
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.

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?
No
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] 298432 0
Other Collaborative groups
Name [1] 298432 0
Genesis Cancer Care
Country [1] 298432 0
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] 297574 0
None
Name [1] 297574 0
Address [1] 297574 0
Country [1] 297574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299428 0
Bellberry Human Ethics Committee
Ethics committee address [1] 299428 0
129 Glen Osmond Road
Eastwood
SA 5063
Ethics committee country [1] 299428 0
Australia
Date submitted for ethics approval [1] 299428 0
Approval date [1] 299428 0
31/05/2017
Ethics approval number [1] 299428 0
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] 2601 2601 0 0
/AnzctrAttachments/374328-NDROR Master Data Point List.docx (Supplementary information)

Contacts
Principal investigator
Name 80370 0
Dr Lynda Spelman
Address 80370 0
Specialist Connect Services
Suite 18, Level 1
250 Ipswich Rd
Woolloongabba
Brisbane QLD 4102
Country 80370 0
Australia
Phone 80370 0
+61 7 30391300
Fax 80370 0
Email 80370 0
[email protected]
Contact person for public queries
Name 80371 0
Lynda Spelman
Address 80371 0
Specialist Connect Services
Suite 18, Level 1
250 Ipswich Rd
Woolloongabba
Brisbane QLD 4102
Country 80371 0
Australia
Phone 80371 0
+61 7 3039 1300
Fax 80371 0
Email 80371 0
[email protected]
Contact person for scientific queries
Name 80372 0
Lynda Spelman
Address 80372 0
Specialist Connect Services
Suite 18, Level 1
250 Ipswich Rd
Woolloongabba
Brisbane QLD 4102
Country 80372 0
Australia
Phone 80372 0
+ 61 7 3039 1300
Fax 80372 0
Email 80372 0
[email protected]

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 [email protected] 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
SourceTitleYear of PublicationDOI
EmbasePreliminary 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.2022https://dx.doi.org/10.1080/09546634.2022.2067814
EmbaseRadiotherapy, 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.2022https://dx.doi.org/10.1159/000521067
EmbaseResponse to: Radiation Oncology Viewpoint: Wide-field radiation therapy for skin cancerisation-Have we forgotten what we learned?.2023https://dx.doi.org/10.1111/1754-9485.13531
Dimensions AIEfficacy 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 cancers2023https://doi.org/10.1002/jvc2.312
N.B. These documents automatically identified may not have been verified by the study sponsor.