Basal Cell Carcinoma
Conditions
Brief summary
The purpose of this study is to determine the narrowest excision margin for head and neck Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network® (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are evaluated.
Detailed description
Basal Cell Carcinoma (BCC) is the most common skin cancer in the US. Most are treated by surgical excision. Excision margins vary by tumor size, anatomic location, histological subtype, and surgeon preference. Published recommendations and follow up observation times vary. Current clinical practice supports the 4 mm excision margin; however, this can be a disservice to the patient by potentially excising additional normal tissue unnecessarily and yielding larger scars. Considering healthcare costs, both the excision and repair components are usually billed by size measurements. Determining the narrowest excision margin to give an acceptable clinical cure could feasibly reduce this expenditure.
Interventions
PROCEDURELow-Risk BCC Excisional Margins
After the head and neck basal cell carcinomas satisfy the National Comprehensive clinical and histopathological criteria, all tumors are excised at the 2 mm margin.
Sponsors
Advanced Aesthetics
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient has a BCC \<10mm on their cheeks, forehead, scalp & neck or \<6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular & postauricular, temple & ear * The BCC has well defined borders * The BCC is primary * The Patient is not immunosuppressed * The BCC is not located at a site of prior radiation therapy * The histologic subtype is nodular or superficial * There is no perineural involvement
Exclusion criteria
* Patient has a BCC \>or=10mm on their cheeks, forehead, scalp & neck or \>or=6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular & postauricular, temple & ear * The BCC has poorly defined borders * The BCC is recurrent * The Patient is immunosuppressed * The BCC is located at a site of prior radiation therapy * The histologic subtype is aggressive * There is perineural involvement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC | 3 years |
Countries
United States
Outcome results
None listed