Recruiting
Phase 3

Permanent vs. Frozen

Sponsor:

Queen's University

Code:

NCT00663650

Conditions

Basal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Permanent Section Control

Frozen Section Control

Study Details

Brief summary:

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.

Conditions

Basal Cell Carcinoma

Study ID

NCT00663650

Start date

Aug, 2008

Status verified date

Jul, 2011

Completion date

Jun, 2013

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

290 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

Permanent Section Control

active comparator: 2

Frozen Section Control

Interventions

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

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Vladimir Kratky, MD, FRCSC

613-544-3400kratkyv@queensu.ca

Locations

Hotel Dieu Hospital

Recruiting

Kingston, Ontario, Canada, K7L 5G2

More Information

Sponsor

Queen's University

Last update posted

Jul 12, 2011

Last verified

Jul, 2011

Keywords

  • Basal Cell Carcinoma
  • BCC
  • Periocular BCC
  • Frozen Section Control
  • Permanent Section Control
  • Recurrence Rates

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2011-07-12.