Effectiveness of Narrow Margins in Patients With Low-Risk Basal Cell Carcinoma Undergoing Surgery
Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Facial Basal Cell Carcinomas
3 other identifiers
interventional
179
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2017
CompletedApril 29, 2025
April 1, 2025
2.2 years
October 12, 2015
April 28, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Success rate for 1 mm margins
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
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 Outcomes (1)
Recurrence rate after 3 years
Up to 3 years
Study Arms (1)
Treatment (surgical excision)
EXPERIMENTALPatients undergo surgical excision of the skin lesion consisting of 1 and 2 mm circumferential margins during visit 1.
Interventions
Eligibility Criteria
You may qualify if:
- 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) -
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, 19107, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Lee, MD
Thomas Jefferson University
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
October 12, 2015
First Posted
October 19, 2015
Study Start
December 7, 2011
Primary Completion
February 1, 2014
Study Completion
May 4, 2017
Last Updated
April 29, 2025
Record last verified: 2025-04