None listed
Conditions
Brief summary
The Skin UNCUTstudy aims to investigate the utility and cost-effectiveness of confocal microscopy in the diagnosis of skin cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a skin lesion identified as a potential skin cancer that requires further diagnostic tests. Study details All participants in this study will undergo a cutaneous confocal microscopy (CM). CM is used to examine the first and second layers of skin to check for abnormal or cancerous cells. It is placed on the skin and is painless. This technique allows your doctor to see a detailed, magnified view of your skin cells, without the need to surgically remove a sample for investigation. Participants will then be randomly allocated (by chance) to one of two groups: one group will be allocated CM review by expert confocalists within 2-7 days of CM where they will receive either a CM recommendation of biopsy indicated or no biopsy indicated. Biopsy will be performed according to national guidelines, depending on lesion characteristics and site PI's (Principal Investigator) discretion as per standard of care. The other group will be allocated no CM review and provision of standard care with surgical biopsy according to clinical guidelines and clinical discretion of their treating physician/site PI. Diagnostic accuracy outcomes, economic impact of CM, patient acceptability and satisfaction are assessed up to 12 months post-randomisation. At the moment, standard care for skin cancer diagnosis is a physical examination of the skin via a surface microscope followed a surgical biopsy. This study aims to evaluate if CM can reduce the need for surgical biopsy. It is hoped that the results from this study determine whether CM can reduce unnecessary skin biopsies and their associated patient burden and healthcare costs and to produce evidence that more precisely characterises presence of malignancy, enabling more confident and appropriate clinical management.
Interventions
All enrolled participants will undergo cutaneous confocal microscopy (CM), the study diagnostic intervention. CM will be performed by the site investigator and is expected to take up to 15 minutes. CM is a microscope applied to the skin that produces horizontal two-dimensional grey-scale digital images of the superficial skin with cellular resolution equivalent to conventional histology with a field of view of 8x8 mm. Confocal images will be reviewed and reported on by one of four expert confoca
All enrolled participants will undergo cutaneous confocal microscopy (CM), the study diagnostic intervention. CM will be performed by the site investigator and is expected to take up to 15 minutes. CM is a microscope applied to the skin that produces horizontal two-dimensional grey-scale digital images of the superficial skin with cellular resolution equivalent to conventional histology with a field of view of 8x8 mm. Confocal images will be reviewed and reported on by one of four expert confocalists within 2-7 days of image acquisition for the intervention arm. Randomisation will occur after the CM procedure, to maintain blinding of allocation concealment and minimise selection bias between the groups. Participant will be randomised to either the intervention or control arm. Intervention Arm: CM Review Group - CM images will be reviewed by CM reader and participants will be allocated to either biopsy indicated or no biopsy indicated between days 2 and 7 post-randomisation. 1. Biopsy indicated: If biopsy is indicated, choice of procedure type and intent will be performed according to national guidelines, depending on lesion characteristics and site PI's discretion as per standard of care. Confocal report will not be provided to ensure blinding is maintained between those with a biopsy indicated per CM review and those who are allocated to standard of care biopsy. Participants in the CM biopsy indicated group have a follow-up for suture removal between days 13 and 49. Remaining follow-up visits are external self-reported outcomes via survey links at 3 and 12 months. 2. No biopsy indicated: If no biopsy is indicated, sites and treating clinicians will receive a confocal report, including the assignment of no biopsy and CM diagnosis. A synoptic CM report will be given to site at the end of the study after unblinding for teaching purposes. Non-biopsied lesions will be reviewed clinically at 3 months and 12 months to check for false negatives and biopsied if there is any concern for missed malignancy according to the PI. This will include sequential clinical and dermascopic photography. Lesions not biopsied at 12 months will be considered truly benign. Participants in the no biopsy group will be aware of allocation. In these cases, sites, investigators and patients will receive the full CM report, including confocal features. The CM report will contain the below information: 1. Surgical biopsy assignment - Biopsy required - Biopsy not required - Insufficient quality: Retake 2. Preferred confocal diagnosis At the end of the study, after unblinding, the site will receive a full report containing: 1. Synoptic report detailing CM features of: - Epidermis - Dermal-Epidermal Junction (DEJ) - Dermis 2. Annotated images 3. Confidence of diagnosis 4. Image quality assessment/artefact
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or over 2. Able to provide informed consent and willing to comply with protocol requirements, including the completion of self-administered assessments of skin cancer risk factors and PROs at the designated time points 3. Able to complete questionnaires in English 4. Able to attend confocal microscopy image acquisition site 5. Able to attend follow-up appointments during weeks 1-7 and 3 and 12 months depending on arm allocation 6. Have a skin lesion identified as a potential cutaneous malignancy (including melanoma and BCC), based on clinical examination and preferably with dermoscopy by their treating medical practitioner or from the Australian Centre of Excellence in Melanoma Imaging and Diagnosis (ACEMID) cohort study 7. One lesion for which the clinical diagnosis of confidence is 2 or 3 at the discretion of the treating clinician (diagnostic confidence score at baseline using a 3-point scale: "1 - very confident", "2 - somewhat confident" and "3 - not confident" 8. Skin lesion is located at a body site amenable to vivascope tissue coupled 1500 CM imaging 9. Only one lesion will be included per participant
Exclusion criteria
1. Lesion at body sites where tissue coupled CM is not amenable to CM imaging, including acral lesions, peri-ungual lesions, deep concavities (e.g. inner canthus), mucosal sites 2. Lesion types which are not evaluable with CM: ulcerated, bleeding, crusted or hyperkeratotic lesions or potential squamous cell carcinomas 3. Lesions referred for mapping/margin assessment rather than diagnosis 4. Lesions for which the clinical diagnosis of malignancy is highly certain 5. Lesions for which preferred clinical diagnosis is squamous cell carcinoma 6. Recurrent lesions, or persistent lesions which have previously been treated with cryotherapy, imiquimod, topical 5-fluorouracil, surgery, radiotherapy or other methods 7. Giant pigmented lesions of >4cm diameter 8. Lesions which cannot be biopsied at the study site 9. Participant in other clinical trial studies may be permitted only after consultation with and approval by the Trial Management Committee (TMC)
Outcome results
None listed