Comparing two methods for marking skin cancer excisions
Dermoscopy vs. Standard Marking Practices for the Completeness of Excision of Keratinocyte Skin Cancers: a Single-centre Randomised Controlled Trial
PHASE4 · Hull University Teaching Hospitals NHS Trust · NCT06627036
This study is testing if using a handheld dermatoscope instead of traditional tools can help doctors remove skin cancer more completely during surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1376 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hull University Teaching Hospitals NHS Trust (other gov) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Hull) |
| Trial ID | NCT06627036 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the effectiveness of surgical removal of keratinocyte skin cancers by comparing two marking techniques: the traditional method using magnifying glasses and theatre lights versus a handheld dermatoscope. Participants will be randomly assigned to one of the two methods before undergoing surgery. The goal is to determine if the dermatoscope can improve the completeness of cancer removal, potentially reducing the need for additional treatments. The study addresses a significant issue, as current methods leave a portion of cancers unremoved in up to 11% of cases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for excision of suspected keratinocyte skin cancer lesions.
Not a fit: Patients with benign lesions or those whose lesions are inaccessible for dermoscopic assessment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to higher rates of complete cancer removal, reducing the need for further surgeries and hospital stays for patients.
How similar studies have performed: While similar studies have explored various techniques for skin cancer excision, the specific use of a dermatoscope in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older who are scheduled for the excision of a suspected non-melanoma skin cancer lesion as part of a day-case surgery list at Hull University Teaching Hospitals are eligible for inclusion in the study. Exclusion Criteria: * Lesions that are inaccessible to dermoscopic assessment due to anatomical locations or conditions that prevent effective use of the dermatoscope. * Lesions that are determined to be benign or pigmented upon initial evaluation and therefore do not meet the criteria for suspected keratinocyte skin cancer. * Lesions scheduled for incisional, punch, or shave biopsy procedures, as these methods do not provide complete peripheral margin clearance. * Lesions that are histologically confirmed as benign following excision and examination by a pathologist. * Patients who decline to participate in the study. * Patients who are unable to provide informed consent due to a lack of mental capacity or other reasons.
Where this trial is running
Hull
- Castle Hill Hospital — Hull, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Joshua Totty, MBBS MRCS PGCert MD(Res) FHEA — Hull York Medical School
- Study coordinator: Christos Vosinakis
- Email: hyp-tr.hullplasticsresearch@nhs.net
- Phone: 01482622185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keratinocyte Skin Cancer, Keratinocyte Cancer, Skin Cancer, Loupe magnification, Dermoscopy