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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Recurrence rate after 3 years [ Time Frame: Up to 3 years ]

Original Secondary Outcome: Same as current

Information By: Thomas Jefferson University

Dates:
Date Received: October 12, 2015
Date Started: December 7, 2011
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017