Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas

NCT ID: NCT01903239

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2017-01-31

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.

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-Risk BCC Excisional Margins

This is a study investigating the efficiency of 1-2 mm margins for the excision of low-risk basal cell carcinoma.

Group Type: OTHER

Low-Risk BCC Excisional Margins

Intervention Type: PROCEDURE

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.

Interventions

Low-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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Aesthetics

UNKNOWN

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason B Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Jefferson Dermatology Associates

Locations

Advanced Aesthetics

Bensalem, Pennsylvania, United States

Jefferson Dermatology Associates

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB#11D.479

Identifier Type: -

Identifier Source: org_study_id