Superficial Basal Cell CarcinomaNCT00994240
Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC
A study testing Electrodessication & Curettage in people with Superficial Basal Cell Carcinoma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Basal Cell Carcinoma
- What is being tested?
- Electrodessication & Curettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Untreated, biopsy proven superficial type basal cell carcinoma (BCC-S) on the trunk and/or extremities
- Age greater than 21
- Women with childbearing potential (including those who are pregnant/lactating)
- Able to provide written informed consent
Who cannot join
- Aggressive histology on initial biopsy (i.e. morpheaform, infiltrative, desmoplastic, or purely micronodular)
- Prior history of BCC or other skin cancer at the same location
- Lesion > 2 cm
- Patients with basal cell nevus syndrome
- Transplant patients
- Immunocompromised patients
Show all 10Show fewer
- Recurrent BCC
- Greater than 2 BCC-S on the trunk and/or extremities
- Prisoners
- Allergy to lidocaine or epinephrine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison, Department of Dermatology
Madison, Wisconsin, 53715
About this study
Official title: Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study
This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED\&C x 1 cycle or ED\&C x 3 cycles) using computer generated random numbers. One cycle of ED\&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED\&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED\&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.
- Conditions
- Superficial Basal Cell Carcinoma
- Being tested
- Electrodessication & Curettage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrodessication & CurettageProcedure or surgery
Electrodessication \& Curettage 1 or 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| ED&C times 3 cycles | Active comparator | Not described Receives: Procedure: Electrodessication & Curettage |
| ED & C times 1 cycle | Active comparator | Not described Receives: Procedure: Electrodessication & Curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
Clinical evidence of BCC recurrence post treatment
Measured: base line, every 3 months until 12 month completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startMay 2008
- Primary completionAug 2013
- Study completionSep 2013
Why it stopped: slow enrollment, lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Superficial Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Skin Cancer Foundation, Dermatology Foundation
- Responsible party
- Sponsor
- Investigators
- Eric Berg, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994240
- Sponsor's protocol ID
- H-2007-0252
- Other IDs
- PRMC_CO08303
- Status last verified
- Feb 2015
- First submitted
- 9 Oct 2009
- Last updated
- 27 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00994240
- Acronym / sponsor ID
- H-2007-0252
- Conditions
- Superficial Basal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment, lack of funding
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Skin Cancer Foundation, Dermatology Foundation
- Study start
- May 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Posted 27 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED\&C x 1 cycle or ED\&C x 3 cycles) using computer generated random numbers. One cycle of ED\&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED\&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED\&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED&C times 3 cycles | Active comparator | Procedure: Electrodessication & Curettage |
| ED & C times 1 cycle | Active comparator | Procedure: Electrodessication & Curettage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Untreated, biopsy proven superficial type basal cell carcinoma (BCC-S) on the trunk and/or extremities
- Age greater than 21
- Women with childbearing potential (including those who are pregnant/lactating)
- Able to provide written informed consent
Key exclusion criteria (10 listed)
- Aggressive histology on initial biopsy (i.e. morpheaform, infiltrative, desmoplastic, or purely micronodular)
- Prior history of BCC or other skin cancer at the same location
- Lesion > 2 cm
- Patients with basal cell nevus syndrome
- Transplant patients
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 |
|---|---|---|
| Electrodessication & CurettageElectrodessication \& Curettage 1 or 3 cycles | Procedure or surgery | ED & C times 1 cycle, ED&C times 3 cycles |
Primary outcome
Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
Time frame: base line, every 3 months until 12 month completion
Clinical evidence of BCC recurrence post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eric Berg, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrodessication & Curettage in people with Superficial Basal Cell Carcinoma, run by University of Wisconsin, Madison at 1 site 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 27 Feb 2015. 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 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?
Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C. (time frame: base line, every 3 months until 12 month completion). 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 27 Feb 2015.