Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01903239
Recruitment Status : Unknown
Verified February 2016 by Thomas Jefferson University.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2013
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
Advanced Aesthetics
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Procedure: Low-Risk BCC Excisional Margins Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 179 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
Study Start Date : November 2011
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Low-Risk BCC Excisional Margins
This is a study investigating the efficiency of 1-2 mm margins for the excision of low-risk basal cell carcinoma.
Procedure: Low-Risk BCC Excisional Margins
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 Measures :
  1. Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903239


Locations
Layout table for location information
United States, Pennsylvania
Advanced Aesthetics
Bensalem, Pennsylvania, United States, 19020
Jefferson Dermatology Associates
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Advanced Aesthetics
Investigators
Layout table for investigator information
Principal Investigator: Jason B Lee, MD Jefferson Dermatology Associates

Layout table for additonal information
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01903239     History of Changes
Other Study ID Numbers: IRB#11D.479
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell