Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000541505p
Ethics application status
Not yet submitted
Date submitted
8/04/2024
Date registered
30/04/2024
Date last updated
30/04/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Oral cancer diagnosis using a novel ultrasound elastography device.
Scientific title
A study to differentiate oral cancer based on elasticity parameters using a novel ultrasound device in patients with oral lesions
Secondary ID [1] 312037 0
None
Universal Trial Number (UTN)
U1111-1305-8849
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oral cancer 333294 0
Condition category
Condition code
Cancer 329981 329981 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20 patients will be recruited from patients referred to the Oral Medicine Unit at the Faculty of Dentistry, University of Otago for suspicion of cancer.

Ultrasound measurements will be made using the Periomedic ultrasound device. The protocol followed is identical to that followed in our previous pilot study, conducted with HDEC Ethics approval (ACTRN12623000463673). Ultrasound recordings of the lesion will be obtained by touching the tip of the device, covered by a latex sterile sheath. The lesion may be supported using sterile aluminum foil. Medical-grade glycerol will be applied external to the sterile sheath to act as an ultrasound coupling medium. Three to five readings will be taken, each requiring approximately 10 seconds. The collected data will be saved using anonymous numbers assigned to identify each participant’s dataset.
The intervention will be administered by clinician who manages oral cancer patients.
Intervention code [1] 328236 0
Diagnosis / Prognosis
Comparator / control treatment
Elasticity of lesions determined by histopathology to be malignant (test) will be compared to non-malignant lesion (control). Biopsy, which is part of clinical routine, will be obtained from the lesion and sent to oral pathology laboratory in the Dental School. They will process and stain the tissue for pathologist's inspection. Oral pathologist will then examine the slide and report malignancy status.
Control group
Active

Outcomes
Primary outcome [1] 337747 0
Malignancy
Timepoint [1] 337747 0
Measured once at the time of ultrasound
Secondary outcome [1] 433108 0
Malignancy
Timepoint [1] 433108 0
A week after ultrasound measurement, during histopathology slide assessment. Presence of the subject is not involved at this time-point.

Eligibility
Key inclusion criteria
An oral lesion “causing suspicion of intraepithelial neoplasia” or frank malignancy necessitating immediate biopsy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Orofacial cancers that are not in the oral cavity, such as cancer of the pinna, skin cancers and melanoma will be excluded.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26209 0
New Zealand
State/province [1] 26209 0

Funding & Sponsors
Funding source category [1] 316117 0
Commercial sector/Industry
Name [1] 316117 0
Periomedic Limited
Country [1] 316117 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Periomedic Limited
Address
Country
New Zealand
Secondary sponsor category [1] 318294 0
None
Name [1] 318294 0
None
Address [1] 318294 0
Country [1] 318294 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314949 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314949 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 314949 0
New Zealand
Date submitted for ethics approval [1] 314949 0
03/05/2024
Approval date [1] 314949 0
Ethics approval number [1] 314949 0

Summary
Brief summary
An ultrasound device developed for periodontal disease diagnosis will be tested for its capability to distinguish cancerous lesions from non-cancerous lesions based on elasticity parameters. Patients referred to dental school by primary physician for biopsy followed by histopathology of suspected cancer lesion will be approached. After obtaining consent, the device will be touched to the lesion and measurements obtained. These will be correlated to malignancy status of the lesion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133214 0
Prof Warwick Duncan
Address 133214 0
Faculty of Dentistry University of Otago 310 Great King Street Dunedin 9016
Country 133214 0
New Zealand
Phone 133214 0
+64 3 479 7110
Fax 133214 0
Email 133214 0
warwick.duncan@otago.ac.nz
Contact person for public queries
Name 133215 0
Warwick Duncan
Address 133215 0
Faculty of Dentistry University of Otago 310 Great King Street Dunedin 9016
Country 133215 0
New Zealand
Phone 133215 0
+64 3 479 7110
Fax 133215 0
Email 133215 0
warwick.duncan@otago.ac.nz
Contact person for scientific queries
Name 133216 0
Warwick Duncan
Address 133216 0
Faculty of Dentistry University of Otago 310 Great King Street Dunedin 9016
Country 133216 0
New Zealand
Phone 133216 0
+64 3 479 7110
Fax 133216 0
Email 133216 0
warwick.duncan@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21904Study protocol  warwick.duncan@otago.ac.nz
22143Ethical approval  warwick.duncan@otago.ac.nz



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.