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

Primary Purpose

Basal Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-Risk BCC Excisional Margins
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Advanced Aesthetics
  • Jefferson Dermatology Associates

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Low-Risk BCC Excisional Margins

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 15, 2013
Last Updated
February 4, 2016
Sponsor
Thomas Jefferson University
Collaborators
Advanced Aesthetics
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1. Study Identification

Unique Protocol Identification Number
NCT01903239
Brief Title
Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
Official Title
Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Advanced Aesthetics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Basal Cell Carcinoma (BCC) is the most common skin cancer in the US. Most are treated by surgical excision. Excision margins vary by tumor size, anatomic location, histological subtype, and surgeon preference. Published recommendations and follow up observation times vary. Current clinical practice supports the 4 mm excision margin; however, this can be a disservice to the patient by potentially excising additional normal tissue unnecessarily and yielding larger scars. Considering healthcare costs, both the excision and repair components are usually billed by size measurements. Determining the narrowest excision margin to give an acceptable clinical cure could feasibly reduce this expenditure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
179 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Risk BCC Excisional Margins
Arm Type
Other
Arm Description
This is a study investigating the efficiency of 1-2 mm margins for the excision of low-risk basal cell carcinoma.
Intervention Type
Procedure
Intervention Name(s)
Low-Risk BCC Excisional Margins
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason B Lee, MD
Organizational Affiliation
Jefferson Dermatology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Aesthetics
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
Facility Name
Jefferson Dermatology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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