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Completed

NCT Number: NCT02579551

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Location
  • Area M tumor size > or = to 10 mm
  • Area H tumor size > or = to 6 mm
  • Poorly defined borders
  • Recurrent BCC
  • Patient is immunosuppressed
  • There has been prior radiotherapy to the site -

Treatment and study plan

therapeutic conventional surgery

Procedure

Undergo surgical excision

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Recurrence rate after 3 years

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2017
First posted
Oct 19, 2015
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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