Carcinoma, Basal CellNCT00515970
Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas
A study testing Curettage, Deep excision and Shave excision in people with Carcinoma, Basal Cell, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys local anatomic structures. There are various treatment alternatives with different recurrence rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and the procedure is relatively expensive. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- Curettage, Deep excision and Shave excision
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Dec 2014
- 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
- Clinical or histologic diagnosis of BCC
- Patient Dependent Exclusion Criteria:
- > 5 BCCs at presentation
- Immunosuppressive drugs
- Pregnancy
- Disability to give informed consent
Show all 19Show fewer
- Synchronous participation in other studies
- Progeroid syndromes
- Other malignant tumors, except for BCC and squamous cell carcinoma, or monoclonal neoplasms of the hematopoietic or immune system
- Critical illness precluding sufficient follow-up visits
- Tumor Exclusion Criteria:
- Recurrent BCC
- Nodular BCC with an exophytic part of > 1.5 mm above skin level
- Nodular BCC with a diameter of > 10 mm
- Superficial BCC with a diameter of > 20 mm
- Ulceration
- Scarring
- Blurred margins
- Histopathologic evidence of a tumor type different from nodular or superficial BCC
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, Eberhard Karls University
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Prospective Randomized Trial: Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas
Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys local anatomic structures. There are various treatment alternatives with different recurrence rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are expensive therapies with high recurrence rates, that lack histologic evidence of BCC. Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than after surgical excision.
This prospective, randomized trial compares recurrence rates, cosmetic outcome, and surgery-related complications after curettage versus surgical excision in nodular and superficial BCC. About 600 tumors will be included. One half is treated by curettage, the other half by surgical excision. The follow-up period is four years. If the difference between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related complications are not worse after curettage, surgical excision must be considered an overtreatment.
Read the detailed description
- First presentation of a patient with clinical or histopathological diagnosis of BCC
- Study patient number, first and surname, date of birth and gender are listed in a distinct file.
- Informed consent
- Whole body screening for skin cancer
- In- or exclusion of the patient. If the patient is excluded, no more data are obtained.
- Recording of the following features in an electronic file:
- Number of BCCs
- Anatomic location
- Lip
- Eyelid
- Ear
- Nose
- Other parts of the face
- Scalp or neck
- Trunk
- Arm, hand, or shoulder
- Leg, foot, or hip
- Position
- Ventral or dorsal. If the tumor is located at the lateral margin of ventral and dorsal, it is considered ventral.
- Right, left, midline
- Distinct BCCs are numbered. To ensure future distinction of different tumors, numbering starts with the most up-right-ventral tumor and ends with the most down-left-dorsal one. Numbering continues with BCCs that appear later during the period of recruitment.
- Diameter in mm
- In- or exclusion of the tumor
- Photographs of the included BCCs
- Randomization is performed by the Department of Biostatistics (distance to the Department of Dermatology = 1.7 km) with envelopes containing the assigned study arm. The study physician calls one of four staff members of the Department of Biostatistics and asks for randomization. The envelopes are not opened unless the electronic data file is completed by the study physician.
- Disinfection
- Local anesthesia
- Surgery
- Dressing
- If histopathology discovers another BCC type than nodular or superficial or even another tumor than BCC, then the tumor is excluded.
- Follow-up visit 3 and 6 months (+/- 30 days) after the operation. In BCCs that had to be operated in >1 step, the day of the follow-up visit refers to the initial operation.
- In case of clinical suspicion of recurrence of BCC a punch biopsy is taken. If the biopsy confirms recurrence, the endpoint is achieved.
- If BCCs must be added to a patient during the recruitment period, follow-up visits always refer to the latest BCC.
- If the patient visits our department not within the defined follow-up period, the appointment is not recorded (except confirmation of recurrence).
- Patients who provide no feedback receive phone calls.
- If a patient or a private practitioner suspect a recurrence of BCC beyond a defined follow-up period, of course, the patient is invited as early as possible to our department, where a biopsy will be taken.
- The patient receives a letter containing a list of the BCCs treated within the study. The private practitioner is to be visited with the list after 12, 24, and 36 months (+/- 30 days) referring to the last operation within the recruitment period. The letter contains a questionnaire about scar size and suspicion of recurrence of BCC. The practitioner or the patient return the questionnaire with the answers to our department. If recurrence is suspected we take a biopsy.
- When follow-up is closed for an individual patient, the reason is recorded:
- Planned end of follow-up after 48 months.
- Patient has moved.
- Death (date of death).
- Consent withdrawn.
- Patient has become meanwhile so ill or high-maintenance that no more follow-up visits can be planned.
- Recurrence of all of the patient's BCCs.
- Statistic evaluation is based on an intention-to-treat-analysis.
- The trial is designed to prove the equivalence of treatment modalities. A statistic test is used for evaluation, including the Kaplan-Meier-method. When all 4 study arms contain 116 BCCs, a 2-group-test on the equivalence of ratios with a 1-sided significance level of 0.05 will have a power of 80% to disprove the null hypothesis. The null hypothesis is that standard and test method are not equivalent (ratio difference delta T - delta S ≥ 0.15). Then the alternative hypothesis is more probable, meaning that the ratios in both groups are equivalent supposed that the expected ratio difference is 0.07 and the ratio within the standard group is 0.03 (according to an expected recurrence rate of 3% in the surgical excision study arm).
- Conditions
- Carcinoma, Basal Cell
- Being tested
- Curettage, Deep excision, Shave excision
- Keywords
- Carcinoma, Basal Cell, Curettage, Excision, Recurrence, Complication, Esthetic outcome
- Medical subject headings
- Carcinoma, Basal Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurettageProcedure or surgery
Curettage without subcutaneous tissue using a 7 mm ring curette and the "fountain-pen technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The curette is held between the thumb, index and middle finger. This method of holding enables precise guiding of the instrument, so that the piece of tissue can be removed in one well-targeted incision. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining. Measurement of tumor thickness in mm.
Deep excisionProcedure or surgery
12 o'clock mark. Excision with a scalpel down to the subcutaneous level. Plastic reconstruction. Three vertical, parallel bread loaf sections for histology. Preparation with paraffin. Staining with hematoxylin-eosin. Histologic diagnosis including report of tumor thickness in mm. Comment on complete removal (R0 versus R1). In case of R1 excision directed reoperations are performed until R0 is achieved.
Shave excisionProcedure or surgery
Shave excision with a safety margin, using a scalpel. Wound healing by secondary intention. Preparation with paraffin. Parallel vertical bread loaf sections for histology. Staining with hematoxylin-eosin. Histologic diagnosis. Comment on complete removal (R0 versus R1). In case of R1 excision a reoperation is performed until R0 is achieved.
CurettageProcedure or surgery
Curettage with a 7 mm ring curette with the "potato-peeler technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The handle of the curette is held in the distal inter-digital fold of the index finger, and supported by the other fingers of the curetting hand. The thumbs serve to provide a stable base. This technique makes it possible to guide the instrument, applying greater pressure, but accuracy is reduced. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clinical or histologic diagnosis of nodular BCC Receives: Procedure: Curettage |
| 2 | Active comparator | Clinical or histologic diagnosis of nodular BCC Receives: Procedure: Deep excision |
| 3 | Experimental | Clinical or histologic diagnosis of superficial BCC Receives: Procedure: Curettage |
| 4 | Active comparator | Clinical or histologic diagnosis of superficial BCC Receives: Procedure: Shave excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of BCC, confirmed by biopsy
Measured: 4 years after surgery
Secondary outcomes (12)
Secondary hemorrhage as remembered by the patient
Measured: 3 months (plus or minus 30 days) after surgery
Wound infection as remembered by the patient
Measured: 3 months (plus or minus 30 days) after surgery
Hypesthesia after surgery
Measured: 3 months (plus or minus 30 days) after surgery
Keloid
Measured: 3 months (plus or minus 30 days) after surgery
Functional impairment or disfigurement by the scar. Keloid is always a disfiguring scar. If the scar is recognized as keloid, the measure "disfigurement" cannot be used here.
Measured: 3 months (plus or minus 30 days) after surgery
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the patient
Measured: 3, 6, 12, 24, 36, and 48 months (plus or minus 30 days) after surgery
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the study physician
Measured: 3, 6, 12, and 48 months (plus or minus 30 days) after surgery
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by a private practitioner
Measured: 12, 24, and 36 months (plus or minus 30 days) after surgery
Scar length in mm
Measured: 6 and 48 months (plus or minus 30 days) after surgery
Scar width in mm, perpendicular to its length
Measured: 6 and 48 months (plus or minus 30 days) after surgery
Color of the scar: hyperpigmented, hypopigmented, or erythematous
Measured: 6 and 48 months (plus or minus 30 days) after surgery
Level of the scar: atrophic, skin level, hypertrophic, or keloid
Measured: 6 and 48 months (plus or minus 30 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Problems with the electronic data collection program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Helmut Breuninger, M.D., Study chair, Department of Dermatology, Eberhard Karls University Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515970
- Sponsor's protocol ID
- E.03.26007.1
- Status last verified
- Jun 2010
- First submitted
- 13 Aug 2007
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial: Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas
- ClinicalTrials.gov ID
- NCT00515970
- Acronym / sponsor ID
- E.03.26007.1
- Conditions
- Carcinoma, Basal Cell
- Keywords
- Carcinoma, Basal Cell, Curettage, Excision, Recurrence, Complication, Esthetic outcome
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Problems with the electronic data collection program
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Aug 2007 (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.
Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys local anatomic structures. There are various treatment alternatives with different recurrence rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are expensive therapies with high recurrence rates, that lack histologic evidence of BCC. Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than after surgical excision.
This prospective, randomized trial compares recurrence rates, cosmetic outcome, and surgery-related complications after curettage versus surgical excision in nodular and superficial BCC. About 600 tumors will be included. One half is treated by curettage, the other half by surgical excision. The follow-up period is four years. If the difference between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related complications are not worse after curettage, surgical excision must be considered an overtreatment.
Detailed description
- First presentation of a patient with clinical or histopathological diagnosis of BCC
- Study patient number, first and surname, date of birth and gender are listed in a distinct file.
- Informed consent
- Whole body screening for skin cancer
- In- or exclusion of the patient. If the patient is excluded, no more data are obtained.
- Recording of the following features in an electronic file:
- Number of BCCs
- Anatomic location
- Lip
- Eyelid
- Ear
- Nose
- Other parts of the face
- Scalp or neck
- Trunk
- Arm, hand, or shoulder
- Leg, foot, or hip
- Position
- Ventral or dorsal. If the tumor is located at the lateral margin of ventral and dorsal, it is considered ventral.
- Right, left, midline
- Distinct BCCs are numbered. To ensure future distinction of different tumors, numbering starts with the most up-right-ventral tumor and ends with the most down-left-dorsal one. Numbering continues with BCCs that appear later during the period of recruitment.
- Diameter in mm
- In- or exclusion of the tumor
- Photographs of the included BCCs
- Randomization is performed by the Department of Biostatistics (distance to the Department of Dermatology = 1.7 km) with envelopes containing the assigned study arm. The study physician calls one of four staff members of the Department of Biostatistics and asks for randomization. The envelopes are not opened unless the electronic data file is completed by the study physician.
- Disinfection
- Local anesthesia
- Surgery
- Dressing
- If histopathology discovers another BCC type than nodular or superficial or even another tumor than BCC, then the tumor is excluded.
- Follow-up visit 3 and 6 months (+/- 30 days) after the operation. In BCCs that had to be operated in >1 step, the day of the follow-up visit refers to the initial operation.
- In case of clinical suspicion of recurrence of BCC a punch biopsy is taken. If the biopsy confirms recurrence, the endpoint is achieved.
- If BCCs must be added to a patient during the recruitment period, follow-up visits always refer to the latest BCC.
- If the patient visits our department not within the defined follow-up period, the appointment is not recorded (except confirmation of recurrence).
- Patients who provide no feedback receive phone calls.
- If a patient or a private practitioner suspect a recurrence of BCC beyond a defined follow-up period, of course, the patient is invited as early as possible to our department, where a biopsy will be taken.
- The patient receives a letter containing a list of the BCCs treated within the study. The private practitioner is to be visited with the list after 12, 24, and 36 months (+/- 30 days) referring to the last operation within the recruitment period. The letter contains a questionnaire about scar size and suspicion of recurrence of BCC. The practitioner or the patient return the questionnaire with the answers to our department. If recurrence is suspected we take a biopsy.
- When follow-up is closed for an individual patient, the reason is recorded:
- Planned end of follow-up after 48 months.
- Patient has moved.
- Death (date of death).
- Consent withdrawn.
- Patient has become meanwhile so ill or high-maintenance that no more follow-up visits can be planned.
- Recurrence of all of the patient's BCCs.
- Statistic evaluation is based on an intention-to-treat-analysis.
- The trial is designed to prove the equivalence of treatment modalities. A statistic test is used for evaluation, including the Kaplan-Meier-method. When all 4 study arms contain 116 BCCs, a 2-group-test on the equivalence of ratios with a 1-sided significance level of 0.05 will have a power of 80% to disprove the null hypothesis. The null hypothesis is that standard and test method are not equivalent (ratio difference delta T - delta S ≥ 0.15). Then the alternative hypothesis is more probable, meaning that the ratios in both groups are equivalent supposed that the expected ratio difference is 0.07 and the ratio within the standard group is 0.03 (according to an expected recurrence rate of 3% in the surgical excision study arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: CurettageClinical or histologic diagnosis of nodular BCC |
| 2 | Active comparator | Procedure: Deep excisionClinical or histologic diagnosis of nodular BCC |
| 3 | Experimental | Procedure: CurettageClinical or histologic diagnosis of superficial BCC |
| 4 | Active comparator | Procedure: Shave excisionClinical or histologic diagnosis of superficial BCC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Clinical or histologic diagnosis of BCC
- > 5 BCCs at presentation
- Immunosuppressive drugs
- Pregnancy
- Disability to give informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CurettageCurettage without subcutaneous tissue using a 7 mm ring curette and the "fountain-pen technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The curette is held between the thumb, index and middle finger. This method of holding enables precise guiding of the instrument, so that the piece of tissue can be removed in one well-targeted incision. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining. Measurement of tumor thickness in mm. | Procedure or surgery | 1 |
| Deep excision12 o'clock mark. Excision with a scalpel down to the subcutaneous level. Plastic reconstruction. Three vertical, parallel bread loaf sections for histology. Preparation with paraffin. Staining with hematoxylin-eosin. Histologic diagnosis including report of tumor thickness in mm. Comment on complete removal (R0 versus R1). In case of R1 excision directed reoperations are performed until R0 is achieved. | Procedure or surgery | 2 |
| Shave excisionShave excision with a safety margin, using a scalpel. Wound healing by secondary intention. Preparation with paraffin. Parallel vertical bread loaf sections for histology. Staining with hematoxylin-eosin. Histologic diagnosis. Comment on complete removal (R0 versus R1). In case of R1 excision a reoperation is performed until R0 is achieved. | Procedure or surgery | 4 |
| CurettageCurettage with a 7 mm ring curette with the "potato-peeler technique" (http://www.biopsypunch.com/kuerettagetechnik.htm; accessed on March 13, 2008). The handle of the curette is held in the distal inter-digital fold of the index finger, and supported by the other fingers of the curetting hand. The thumbs serve to provide a stable base. This technique makes it possible to guide the instrument, applying greater pressure, but accuracy is reduced. After macroscopically complete removal, a safety margin is removed with the curette. It is used for histology to distinguish between R0 (excision margin without tumor cells) and R1 resection (excision margin containing tumor cells). Preparation with paraffin. Parallel, vertical sections for histologic diagnosis. Hematoxylin-eosin staining. | Procedure or surgery | 3 |
Primary outcome
Recurrence of BCC, confirmed by biopsy
Time frame: 4 years after surgery
12 secondary outcomes
Secondary hemorrhage as remembered by the patient
Time frame: 3 months (plus or minus 30 days) after surgery
Wound infection as remembered by the patient
Time frame: 3 months (plus or minus 30 days) after surgery
Hypesthesia after surgery
Time frame: 3 months (plus or minus 30 days) after surgery
Keloid
Time frame: 3 months (plus or minus 30 days) after surgery
Functional impairment or disfigurement by the scar. Keloid is always a disfiguring scar. If the scar is recognized as keloid, the measure "disfigurement" cannot be used here.
Time frame: 3 months (plus or minus 30 days) after surgery
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the patient
Time frame: 3, 6, 12, 24, 36, and 48 months (plus or minus 30 days) after surgery
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the study physician
Time frame: 3, 6, 12, and 48 months (plus or minus 30 days) after surgery
Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by a private practitioner
Time frame: 12, 24, and 36 months (plus or minus 30 days) after surgery
Scar length in mm
Time frame: 6 and 48 months (plus or minus 30 days) after surgery
Scar width in mm, perpendicular to its length
Time frame: 6 and 48 months (plus or minus 30 days) after surgery
Color of the scar: hyperpigmented, hypopigmented, or erythematous
Time frame: 6 and 48 months (plus or minus 30 days) after surgery
Level of the scar: atrophic, skin level, hypertrophic, or keloid
Time frame: 6 and 48 months (plus or minus 30 days) after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
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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.
Helmut Breuninger, M.D. study chair
Department of Dermatology, Eberhard Karls University Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curettage, Deep excision and Shave excision in people with Carcinoma, Basal Cell, run by University Hospital Tuebingen at 1 site in Germany.
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 19 inclusion and 0 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: paused, as of the sponsor's last update on 15 Jun 2010. 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 Germany. 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?
Recurrence of BCC, confirmed by biopsy (time frame: 4 years after surgery). 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 15 Jun 2010.