Periocular Basal Cell Carcinoma (BCC): Permanent vs. Frozen Section Pathological Control

July 11, 2011 updated by: Queen's University

A Randomized Clinical Trial in the Surgical Treatment of Basal Cell Carcinoma of the Eyelid: Surgical Excision With Frozen Section vs. Permanent Section Control

This study is an equivalency study designed as a randomized clinical trial. Patients with a biopsy proven nodular periocular basal cell carcinoma (BCC) who have agreed to have surgical excision will be eligible. Study patients will undergo surgical excision of the lesion and then be randomized to having frozen section or permanent section pathological control. For those patients randomized to permanent section control the sample will be sent to pathology and surgical reconstruction will be performed. Patients randomized to frozen section will have additional margins re-excised before reconstruction depending on the pathologic results. Tumor clearance rates after surgical excision will be compared between the two techniques as a primary study question. Patients will be followed long-term to determine recurrence rates in the two groups. The study is designed to determine if the two techniques are equivalent within a given margin of error with respect to outcome measures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Basal cell carcinoma (BCC) accounts for 80-90% of skin cancers and is the most common skin cancer of the periocular region. Surgical excision is considered the gold-standard in therapy. Previous literature has shown comparable recurrence rates of BCC between surgical excision with frozen section control and surgical excision and permanent section control. To data, there are no prospective studies comparing frozen section control with permanent section control. We hypothesize that short term tumor clearance rates between frozen section and permanent section control will be similar and that long-term tumor recurrence rates will be similar between the two techniques. If we find that these two treatment options are equivalent with respect to margin control and recurrence rates, then considerable time and money savings can be accrued through using permanent section control amongst patients with periocular BCC.

The study design is a single-blind randomized controlled trial. Patients who have already agreed to surgical excision of nodular type periocular BCC will be eligible. All patients will undergo a detailed informed consent process. All patients will undergo a punch biopsy to confirm the histopathological diagnosis of BCC. The study design will be a single-blinded, randomized clinical trial. Statistically, the study will be designed as an equivalency study. Prior to randomization the BCC will be excised with 3mm clinical margins in a standard fashion. Subjects will then be randomized to one of two groups: 1. Frozen section control; 2. Permanent section control. For those patients randomized to permanent section control the clinical sample will be sent for pathologic analysis and surgical reconstruction will be performed immediately using standard oculoplastic techniques. Patients randomized to frozen section will have additional margins re-excised if necessary depending on the pathologic results. Oculoplastic reconstruction will be performed after all margins are clear. Patients will undergo examinations at the following times to assess for clinical recurrence: 1. 2 weeks and as necessary thereafter to assess surgical result and wound healing, 2. 6 months, 3. 1 year, 4. yearly up to 5 years.

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vladimir Kratky, MD, FRCSC
  • Phone Number: 2169 613-544-3400
  • Email: kratkyv@queensu.ca

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Recruiting
        • Hotel Dieu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old or greater
  • Diagnosed with clinically nodular BCC in the periocular region confirmed by tissue biopsy
  • Agreeable and medically able to undergo surgical excision of the BCC
  • Able to give informed consent and consent has been signed
  • Able to return for all follow up visits

Exclusion Criteria:

  • BCC greater than 2cm in diameter (based on clinical examination)
  • Patient with a medical condition predisposing to multiple BCC's (ex. basal cell nevus syndrome)
  • Recurrent BCC's (i.e. a BCC that has been treated previously by surgical or other modality and has recurred will not be eligible)
  • Clinically aggressive morpheaform subtype of BCC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Permanent Section Control
Procedure: Permanent Section Control
After surgical excision of the tumor, margins will be sent for permanent section pathologic control to determine if the tumor was completely excised
Active Comparator: 2
Frozen Section Control
Procedure: Frozen Section Control
After surgical excision of the tumor, tumor edges will be analyzed by frozen section at the time of surgery. If tumor margins are positive with the frozen section, additional tissue will be excised and analyzed again. This process will be repeated until all tissue edges are clear of tumor. Finally, the area of tumor excision will be surgically reconstructed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of BCC's that are pathologically clear of tumor cells in the permanent section group compared with the frozen section group (presumably clear for all patients).
Time Frame: 1.5 years
1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical recurrence at 3 years
Time Frame: 4.5 years
4.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Vladimir Kratky, MD, FRCSC, Department of Ophthalmology, Queen's University, Kingston, ON

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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