Basal Cell CarcinomaNCT01903239
Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
A study testing Low-Risk BCC Excisional Margins in people with Basal Cell Carcinoma, run by Thomas Jefferson University at 2 sites in United States.
Trial summary
The purpose of this study is to determine the narrowest excision margin for head and neck Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network® (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an acceptable (95%) clinical cure-rate over a 3 year… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Low-Risk BCC Excisional Margins
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Jan 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has a BCC <10mm on their cheeks, forehead, scalp \& neck or <6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear
- The BCC has well defined borders
- The BCC is primary
- The Patient is not immunosuppressed
- The BCC is not located at a site of prior radiation therapy
- The histologic subtype is nodular or superficial
- There is no perineural involvement
Who cannot join
- Patient has a BCC >or=10mm on their cheeks, forehead, scalp \& neck or >or=6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear
- The BCC has poorly defined borders
- The BCC is recurrent
- The Patient is immunosuppressed
- The BCC is located at a site of prior radiation therapy
- The histologic subtype is aggressive
- There is perineural involvement
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Aesthetics
Bensalem, Pennsylvania, 19020
Jefferson Dermatology Associates
Philadelphia, Pennsylvania, 19107
About this study
The purpose of this study is to determine the narrowest excision margin for head and neck Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network® (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are evaluated.
Read the detailed description
Basal Cell Carcinoma (BCC) is the most common skin cancer in the US. Most are treated by surgical excision. Excision margins vary by tumor size, anatomic location, histological subtype, and surgeon preference. Published recommendations and follow up observation times vary. Current clinical practice supports the 4 mm excision margin; however, this can be a disservice to the patient by potentially excising additional normal tissue unnecessarily and yielding larger scars. Considering healthcare costs, both the excision and repair components are usually billed by size measurements. Determining the narrowest excision margin to give an acceptable clinical cure could feasibly reduce this expenditure.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Low-Risk BCC Excisional Margins
- 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.
Low-Risk BCC Excisional MarginsProcedure or surgery
After the head and neck basal cell carcinomas satisfy the National Comprehensive clinical and histopathological criteria, all tumors are excised at the 2 mm margin.
| Study group | Role | What they receive |
|---|---|---|
| Low-Risk BCC Excisional Margins | Other | This is a study investigating the efficiency of 1-2 mm margins for the excision of low-risk basal cell carcinoma. Receives: Procedure: Low-Risk BCC Excisional Margins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Aesthetics
- Responsible party
- Sponsor
- Investigators
- Jason B Lee, MD, Principal investigator, Jefferson Dermatology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903239
- Sponsor's protocol ID
- IRB#11D.479
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2013
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Prospective Study Evaluating Effectiveness of Narrow Margins for Low-Risk Head and Neck Basal Cell Carcinomas
- ClinicalTrials.gov ID
- NCT01903239
- Acronym / sponsor ID
- IRB#11D.479
- Conditions
- Basal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Advanced Aesthetics
- Study start
- Nov 2011
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 19 Jul 2013 (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.
The purpose of this study is to determine the narrowest excision margin for head and neck Basal Cell Carcinoma (BCC) tumors satisfying the National Comprehensive Cancer Network® (NCCN) low-risk for recurrence clinical and histopathological criteria that gives an acceptable (95%) clinical cure-rate over a 3 year follow-up period. Margins of 1 and 2mm are evaluated.
Detailed description
Basal Cell Carcinoma (BCC) is the most common skin cancer in the US. Most are treated by surgical excision. Excision margins vary by tumor size, anatomic location, histological subtype, and surgeon preference. Published recommendations and follow up observation times vary. Current clinical practice supports the 4 mm excision margin; however, this can be a disservice to the patient by potentially excising additional normal tissue unnecessarily and yielding larger scars. Considering healthcare costs, both the excision and repair components are usually billed by size measurements. Determining the narrowest excision margin to give an acceptable clinical cure could feasibly reduce this expenditure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Risk BCC Excisional Margins | Other | Procedure: Low-Risk BCC Excisional MarginsThis is a study investigating the efficiency of 1-2 mm margins for the excision of low-risk basal cell carcinoma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has a BCC <10mm on their cheeks, forehead, scalp \& neck or <6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear
- The BCC has well defined borders
- The BCC is primary
- The Patient is not immunosuppressed
- The BCC is not located at a site of prior radiation therapy
Key exclusion criteria (7 listed)
- Patient has a BCC >or=10mm on their cheeks, forehead, scalp \& neck or >or=6mm on their central face, eyelids, eyebrows, periorbital, nose, lips, chin, mandible, preauricular \& postauricular, temple \& ear
- The BCC has poorly defined borders
- The BCC is recurrent
- The Patient is immunosuppressed
- The BCC is located at a site of prior radiation therapy
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 |
|---|---|---|
| Low-Risk BCC Excisional MarginsAfter the head and neck basal cell carcinomas satisfy the National Comprehensive clinical and histopathological criteria, all tumors are excised at the 2 mm margin. | Procedure or surgery | Low-Risk BCC Excisional Margins |
Primary outcome
Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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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.
Jason B Lee, MD principal investigator
Jefferson Dermatology Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Risk BCC Excisional Margins in people with Basal Cell Carcinoma, run by Thomas Jefferson University at 2 sites in United States.
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 7 inclusion and 7 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of narrow (1 and 2mm)margin excision of low-risk facial BCC (time frame: 3 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 5 Feb 2016.