Periocular Basal Cell Carcinoma (BCC): Permanent vs. Frozen Section Pathological Control
|ClinicalTrials.gov Identifier: NCT00663650|
Recruitment Status : Unknown
Verified July 2011 by Queen's University.
Recruitment status was: Recruiting
First Posted : April 22, 2008
Last Update Posted : July 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Procedure: Permanent Section Control Procedure: Frozen Section Control||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Clinical Trial in the Surgical Treatment of Basal Cell Carcinoma of the Eyelid: Surgical Excision With Frozen Section vs. Permanent Section Control|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
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.
- 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 ]
- Clinical recurrence at 3 years [ Time Frame: 4.5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663650
|Contact: Vladimir Kratky, MD, FRCSC||613-544-3400 ext email@example.com|
|Hotel Dieu Hospital||Recruiting|
|Kingston, Ontario, Canada, K7L 5G2|
|Principal Investigator:||Vladimir Kratky, MD, FRCSC||Department of Ophthalmology, Queen's University, Kingston, ON|