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

NCT01903239 | Unknown DMC

• 1 other identifier: IRB#11D.479
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 2

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC

  3 years

Study Arms (1)

Low-Risk BCC Excisional Margins

OTHER

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

Procedure: Low-Risk BCC Excisional Margins

Interventions

Low-Risk BCC Excisional Margins 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.

Low-Risk BCC Excisional Margins

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Advanced Aesthetics: collaborator

Study Sites (2)

Advanced Aesthetics

Bensalem, Pennsylvania, 19020, United States

Location

Jefferson Dermatology Associates

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Jason B Lee, MD

  Jefferson Dermatology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: July 19, 2013
• Study Start: November 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

US (2)