Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001460291
Ethics application status
Approved
Date submitted
24/08/2018
Date registered
30/08/2018
Date last updated
8/12/2024
Date data sharing statement initially provided
8/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Facing Clinical Trials - Unlocking facial clues
Scientific title
Facing Clinical Trials - 3D facial analysis hub of children using images to unlock facial clues
Secondary ID [1] 295899 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rare diseases 309369 0
Condition category
Condition code
Human Genetics and Inherited Disorders 308231 308231 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
The photograph will be administered by Ms Lyn Schofield ( RN, PhD) or another similarly trained project officer. The camera operator will be fully versed in the use of a DSLR camera. This involves making sure the camera is set to automatic operation and that the range finder is functional. Once these checks are made, the operator assesses the environment and places the participant in position that ensures that they, and if necessary the parent or carer, are comfortable. If necessary, hair is moved off the face and a hair clip or headband is used to ensure that a clear vision of the face is obtained. When the environment is satisfactory, the operator presses the shutter button and the flash fires. Apart from positioning the participant, this is a non-touch procedure.

Once the image is taken, the operator assesses the fidelity of the image on the camera screen. Alternatively, if the camera is tethered to a laptop computer, the image can similarly be assessed. Points to check are that an optimal line of vision is obtained ie clear ear-to-ear line of site, with no or minimal artefact. If the image is not satisfactory, adjustments are made to the environment, or the participant is re-positioned in order to rectify errors. The image can be shown to the participant and/or parent/carer if they are interested in seeing the resulting image.

Determination of the frequency of imaging will be made on a case by case basis, depending on the condition and the type and length of treatment. For example, a typical series would be images at T 0, 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years.
Intervention code [1] 312225 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307198 0
A longitudinal series of 3D images for each participant, allowing for assessment of treatment response through identification of subtle facial changes over the course of a treatment. Treatment response is assessed by facial morphometrics including dysmorphometric z-score assessments. Subtle facial changes assessed are: holistic assessments of total facial variation (morphometrics); assessment of human phenotype ontology metrics, landmark-based assessments, and facial asymmetry. The images are assessed using the Cliniface software tool. This employs multiple morphometric and non-morphometric algorithms.
Timepoint [1] 307198 0
2 years
Secondary outcome [1] 351097 0
Nil
Timepoint [1] 351097 0
Not applicable

Eligibility
Key inclusion criteria
Children and adults with rare diseases and syndromes - a rare disorder affects fewer than 5 people in 10,000 ,and syndromes are disorders characterised by a set of features with a suspected or known cause
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
3D morphometrics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/12/2024
Actual
Date of last participant enrolment
Anticipated
4/12/2025
Actual
Date of last data collection
Anticipated
9/12/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 11728 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 11729 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 23811 0
6009 - Nedlands
Recruitment postcode(s) [2] 23812 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 300490 0
Government body
Name [1] 300490 0
WA Health
Country [1] 300490 0
Australia
Primary sponsor type
Government body
Name
WA Health
Address
Royal Street
East Perth WA 6000
Country
Australia
Secondary sponsor category [1] 299964 0
University
Name [1] 299964 0
Curtin University
Address [1] 299964 0
Kent Street
Bentley WA 6102
Country [1] 299964 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301290 0
Women and Newborn Health Service King Edward Memorial Hospital (EC00350)
Ethics committee address [1] 301290 0
Ethics committee country [1] 301290 0
Australia
Date submitted for ethics approval [1] 301290 0
01/03/2016
Approval date [1] 301290 0
31/05/2016
Ethics approval number [1] 301290 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86510 0
Dr Petra Helmholz
Address 86510 0
Curtin University
Kent Street
Bentley WA 6102
Country 86510 0
Australia
Phone 86510 0
+61 (8) 9226 3369
Fax 86510 0
Email 86510 0
Petra.Helmholz@curtin.edu.au
Contact person for public queries
Name 86511 0
Petra Helmholz
Address 86511 0
Curtin University
Kent Street
Bentley WA 6102
Country 86511 0
Australia
Phone 86511 0
+61 (8) 9226 3369
Fax 86511 0
Email 86511 0
Petra.Helmholz@curtin.edu.au
Contact person for scientific queries
Name 86512 0
Petra Helmholz
Address 86512 0
Curtin University
Kent Street
Bentley WA 6102
Country 86512 0
Australia
Phone 86512 0
+61 (8) 9226 3369
Fax 86512 0
Email 86512 0
Petra.Helmholz@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in the ethics


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
No additional documents have been identified.