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

NCT00663650 | Unknown Phase 3

• 1 other identifier: 01
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  1.5 years

Secondary Outcomes (1)

• Clinical recurrence at 3 years

  4.5 years

Study Arms (2)

1

ACTIVE COMPARATOR

Permanent Section Control

Procedure: Permanent Section Control

2

ACTIVE COMPARATOR

Frozen Section Control

Procedure: Frozen Section Control

Interventions

Permanent Section Control PROCEDURE

After surgical excision of the tumor, margins will be sent for permanent section pathologic control to determine if the tumor was completely excised

1

Frozen Section Control PROCEDURE

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Vladimir Kratky, MD, FRCSC

  Department of Ophthalmology, Queen's University, Kingston, ON

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Kratky, MD, FRCSC

CONTACT

613-544-3400; kratkyv@queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

CA (1)