Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery

April 28, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

This clinical trial studies the effectiveness of narrow margins in patients with low-risk basal cell carcinoma undergoing surgery to remove skin lesions on the face. A margin is the area of normal tissue around a tumor taken out during surgery to make sure all of the cancer is removed. This clinical trial studies tissue samples to determine the least amount of tissue that must be removed to give an acceptable cure rate. This may allow less normal tissue to be removed from patients and may be a less expensive surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the success rate of narrow margin excisions of low-risk facial basal cell carcinoma (BCC).

SECONDARY OBJECTIVES:

I. To determine the narrowest excision margin for low-risk facial BCC that gives an acceptable (95%) cure rate over a 3 year follow-up period.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Location

    1. Area M (cheeks, forehead, scalp & neck) tumor size < 10 mm
    2. Area H (central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular & postauricular, temple & ear) tumor size < 6 mm
  2. Well-defined borders
  3. Primary BCC
  4. Patient is not immunosuppressed
  5. There has not been prior radiotherapy to the site
  6. Nodular subtype
  7. No perineural involvement-(no neurological deficits grossly) -

Exclusion Criteria:

  1. Location

    1. Area M tumor size > or = to 10 mm
    2. Area H tumor size > or = to 6 mm
  2. Poorly defined borders
  3. Recurrent BCC
  4. Patient is immunosuppressed
  5. There has been prior radiotherapy to the site -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (surgical excision)
Patients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.
Procedure: Therapeutic Conventional Surgery
Undergo surgical excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate for 1 mm margins
Time Frame: Up to 3 years
The success rate for 1 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion.
Up to 3 years
Success rate for 2 mm margins
Time Frame: Up to 3 years
The success rate for 2 mm margin will be calculated along with an exact one-sided 95% confidence interval for the proportion. The success rate will be compared to a null value of 90% using a one-sided exact test of binomial proportion.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate after 3 years
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Jason Lee, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

May 4, 2017

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimated)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11D.479
  • NCI-2015-01624 (Registry Identifier: NCI Trial Identification)
  • JT 2143 (Other Identifier: JeffTrial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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