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Trial registered on ANZCTR


Registration number
ACTRN12614000751673
Ethics application status
Approved
Date submitted
3/04/2014
Date registered
16/07/2014
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Date results provided
8/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the Vivosight system for diagnosis and assistance in the management of cutaneous basal cell carcinoma (BCC)
Scientific title
In the diagnosis of cutaneous BCC, how does the specificity and sensitivity of the Vivosight system compare to skin biopsy in differentiating subtypes.
Secondary ID [1] 284392 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous basal cell carcinoma 291567 0
Condition category
Condition code
Cancer 291945 291945 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Vivosight optical coherence tomography is a type of optical scanner that provides high resolution pictures of the superficial tissue by using very low intensity laser beams without causing any injury or having to cut out the tissue. The scan will be taken twice during the research, once at the baseline visit, and once at 6 month follow up. The scan itself will not take more than 1 minute and will not influence the treatment. If patient has a superficial BCC based on biopsy, the treatment will be topical and these patients will be followed up in 6 months. If patients do not have superficial BCC based on biopsy, they will be advised on appropriate treatment option, but will not be required to have 6 months follow up.
Intervention code [1] 289119 0
Diagnosis / Prognosis
Comparator / control treatment
A skin biopsy is a sample of skin tissue cut out under local anaesthesia. It is the current gold standard in the diagnosis of many skin conditions and is standard clinical practice in the diagnosis of BCCs. Patients will undergo biopsy twice in this study, once at baseline to confirm the diagnosis, and once at 6 month follow up to determine clearance. A skin biopsy takes approximately 5-10 minutes to perform. All patients will undergo both Vivosight optical coherence tomography and skin biopsies.
Control group
Active

Outcomes
Primary outcome [1] 291851 0
Confirmation that optical coherence tomography (OCT) can diagnose superficial BCC with >95% sensitivity and >75% specificity. This will be done by measuring the frequencies of the OCT features in different BCC cases. Significant differences between superficial BCC and other types of BCCs will be evaluated by means of Chi square test of independence. Multivariate analysis and binary logistic regression will be performed for the identification of the independently significant features and for the validation of the efficacy of OCT in distinguishing between superficial BCC and other types of BCC.
Timepoint [1] 291851 0
Primary timepoint will be assessed at recruitment or baseline visit.
Secondary outcome [1] 307663 0
Quantification of how well OCT measures the depth of superficial lesions compared to histology. This will be done by comparing the lesion depth on the OCT scan and the lesion depth on pathology based on the biopsy.
Timepoint [1] 307663 0
This will be assessed at recruitment or baseline visit.
Secondary outcome [2] 307664 0
Agreement between OCT and histology at day 1 and day 180 of follow-up for clearance / treatment failure.
Timepoint [2] 307664 0
Baseline and 180 day follow up

Eligibility
Key inclusion criteria
Patients must be aged 18 years or older; present with pink patch lesions that are suspected superficial basal cell carcinomas; be able to follow trial instructions; and be likely to complete all trial requirements (must be willing to give written informed consent and to allow photographs and images of the selected treatment area).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to give consent or follow trial instructions.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Prior to recruitment, sample size calculation was performed. A total sample size of
165 (which includes 33 subjects with non-superficial BCC) was calculated to achieve 99% power to detect a change in sensitivity from 0.6 to 0.90 using a one-sided binomial test and 100% power to detect a change in specificity from 0.6 to 0.9 using a one-sided binomial test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/03/2014
Actual
27/03/2014
Date of last participant enrolment
Anticipated
26/03/2015
Actual
26/03/2015
Date of last data collection
Anticipated
Actual
26/03/2015
Sample size
Target
120
Accrual to date
Final
168
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7970 0
2060 - North Sydney
Recruitment outside Australia
Country [1] 5961 0
Germany
State/province [1] 5961 0
Berlin

Funding & Sponsors
Funding source category [1] 289035 0
Government body
Name [1] 289035 0
Melanoma Institute of Australia
Country [1] 289035 0
Australia
Primary sponsor type
Government body
Name
Melanoma Institute of Australia
Address
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 308773 0
None
Name [1] 308773 0
Address [1] 308773 0
Country [1] 308773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290835 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 290835 0
Level 6, deLacy Building,
390 Victoria St
Darlinghurst
NSW 2010
Ethics committee country [1] 290835 0
Australia
Date submitted for ethics approval [1] 290835 0
Approval date [1] 290835 0
25/03/2014
Ethics approval number [1] 290835 0
SVH: 14/025

Summary
Brief summary
The purpose of this study is to collect information on the ability of the Vivosight OCT system to distinguish basal cell carcinomas that require surgical treatment from those that would respond to non- invasive therapy based on lesion depth. In the future this might allow the clinician to select the appropriate treatment course without requiring a biopsy to determine how deep the lesion is, preventing possible recurrence in the cases where the lesion is deeper than anticipated.

Who is it for?
All patients with pink patches suspicious for superficial BCC will be recruited into the study at their first visit.

Study details
During the patient’s first visit, a clinical photograph, and dermoscopy photograph of the lesions will be taken. The OCT scan will also be taken, which is a non-invasive, optical imaging technique, lasting less than 1 minute. A skin biopsy will then be taken to confirm the diagnosis. With the results from the skin biopsy, patients will be advised on treatment option. If patient has a superficial BCC, the treatment will be topical and these patients will be followed up in 6 months. If patients do not have superficial BCC, they will be advised on appropriate treatment option, but will not be required to have 6 months follow up. At 6 months, all superficial BCC cases will be followed up with clinical photograph, dermoscopy photograph of the treated lesion. The OCT scan and skin biopsy will be taken again to determine the clearance of the treated BCC. Based on the skin biopsy results, further treatment advice will be given. This will not be part of the protocol and is based on best clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47510 0
Dr Pascale Guitera
Address 47510 0
Melanoma Institute of Australia
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country 47510 0
Australia
Phone 47510 0
+61 2 80050012
Fax 47510 0
Email 47510 0
pascale@guitera.com
Contact person for public queries
Name 47511 0
Sandie Grierson
Address 47511 0
Melanoma Institute of Australia
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country 47511 0
Australia
Phone 47511 0
+61 2 99117200
Fax 47511 0
Email 47511 0
sandie.grierson@melanoma.org.au
Contact person for scientific queries
Name 47512 0
Pascale Guitera
Address 47512 0
Melanoma Institute of Australia
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country 47512 0
Australia
Phone 47512 0
+61 2 80050012
Fax 47512 0
Email 47512 0
pascale@guitera.com

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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Cheng HM, Lo S, Scolyer R, Meekings A, Carlos ... [More Details]

Documents added automatically
No additional documents have been identified.