Basal Cell CarcinomaPhase 3NCT00663650
Periocular Basal Cell Carcinoma (BCC): Permanent vs. Frozen Section Pathological Control
A Phase 3 study of Basal Cell Carcinoma, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
About this study
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
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.
Read the 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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Permanent Section Control, Frozen Section Control
- Keywords
- Basal Cell Carcinoma, BCC, Periocular BCC, Frozen Section Control, Permanent Section Control, Recurrence Rates
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent Section ControlProcedure or surgery
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 ControlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Permanent Section Control Receives: Procedure: Permanent Section Control |
| 2 | Active comparator | Frozen Section Control Receives: Procedure: Frozen Section Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1.5 years
Secondary outcomes (1)
Clinical recurrence at 3 years
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Investigators
- Vladimir Kratky, MD, FRCSC, Principal investigator, Department of Ophthalmology, Queen's University, Kingston, ON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663650
- Sponsor's protocol ID
- 01
- Status last verified
- Jul 2011
- First submitted
- 18 Apr 2008
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00663650
- Acronym / sponsor ID
- 01
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal Cell Carcinoma, BCC, Periocular BCC, Frozen Section Control, Permanent Section Control, Recurrence Rates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Permanent Section ControlPermanent Section Control |
| 2 | Active comparator | Procedure: Frozen Section ControlFrozen Section Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permanent Section ControlAfter surgical excision of the tumor, margins will be sent for permanent section pathologic control to determine if the tumor was completely excised | Procedure or surgery | 1 |
| Frozen Section ControlAfter 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. | Procedure or surgery | 2 |
Primary outcome
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 secondary outcome
Clinical recurrence at 3 years
Time frame: 4.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Kratky, MD, FRCSC principal investigator
Department of Ophthalmology, Queen's University, Kingston, ON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Basal Cell Carcinoma, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Kratky, MD, FRCSC (613-544-3400 ext. 2169, kratkyv@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.