Carcinoma, Basal CellNCT00639652
Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970
An observational study of Carcinoma, Basal Cell, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Currently, we conduct a prospective, randomized trial comparing the outcome of surgical excision with the outcome of curettage in nodular and superficial BCCs. Larger BCCs and micronodular or sclerosing BCCs are not included in the randomized study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- 3D-histology and Shave excision
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Dec 2013
- Phase
- Observational
- 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
Study population: BCCs excluded from the randomized trial NCT00515970
Who may be able to join
- BCCs excluded from the randomized trial NCT00515970
Who cannot join
- Treatment other than with 3D-histology or shave excision (e.g. deep surgical excision without 3D-histology)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Eberhard Karls University, Department of Dermatology
Tübingen, 72076
About this study
Official title: Observational Study: Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970
Currently, we conduct a prospective, randomized trial comparing the outcome of surgical excision with the outcome of curettage in nodular and superficial BCCs. Larger BCCs and micronodular or sclerosing BCCs are not included in the randomized study. They are mainly operated using three-dimensional histology (3D-histology, micrographic surgery). In this observational study we measure the cosmetic result and the recurrence rate of all BCCs not included in the randomized trial.
Read the detailed description
- Disinfection
- Local anesthesia
- Surgery
- Dressing
- Preparation with paraffin for histopathologic evaluation
- Staining with hematoxylin-eosin
- Adjuvant radiotherapy is not applied in any of our patients.
- If histopathology discovers another tumor than BCC, the tumor is excluded.
- If recurrence is suspected, a punch biopsy is taken. If recurrence is confirmed, the endpoint is achieved.
- Patients who provide no feedback receive phone calls.
- The patient receives a letter containing a list of the BCCs treated within the study. She or he is asked to visit the private practitioner with the list after 12 and 48 months (+/- 30 days) referring to the last operation in the recruitment period. The practitioner or the patient return the questionnaire to our department.
- The letter contains a questionnaire about suspicion of recurrence of BCC.
- The patient is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
- The physician is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
- 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
- Meanwhile, the patient has become so ill or high-maintenance that no more follow-up visits can be planned.
- Recurrence of all of the patient's BCCs with histopathologic confirmation.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- 3D-histology, Shave excision
- Keywords
- Carcinoma, Basal Cell, 3D-histology, Micrographic surgery, Mohs surgery, Shave excision, Recurrence, 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.
3D-histologyProcedure or surgery
Also called Micrographic surgery, Histographic surgery, Mohs surgery
The tumor is marked at the 12 o'clock-position. Excision with a safety margin between 2 and 10 mm, depending on tumor size and location. Plastic reconstruction. Removal of the specimen's margins and base as thin layers, using a scalpel. These primarily three-dimensional layers of the specimen's borders are flattened to one level and microscopically screened for tumor cells. 3D-histology is combined with representative vertical sections for histologic diagnosis. Consecutive excisions are performed topographically at the tumor-positive areas and 3D-histology is repeated until tumor-free margins are obtained.
Shave excisionProcedure or surgery
Tumor removal by shave excision with a safety margin. Healing by secondary intention. Histologic diagnosis of BCC type (nodular, superficial, morpheaform, micronodular, other type, mixed type) or diagnosis of another tumor than BCC. Comment on complete removal (R0 versus R1).
| Study group | Role | What they receive |
|---|---|---|
| 1. 3D-histology | Nodular, micronodular, or sclerosing BCCs Receives: Procedure: 3D-histology | |
| 2. Shave excision | Superficial BCCs Receives: Procedure: Shave excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of basal cell carcinoma (BCC)
Measured: Within 4 years after surgery
Secondary outcomes (2)
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 and 48 months 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: 12 and 48 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Helmut Breuninger, M.D., Study chair, Eberhard Karls University Tuebingen, Department of DermatologyKay Brantsch, M.D., Principal investigator, Eberhard Karls University Tuebingen, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639652
- Sponsor's protocol ID
- 16/2008BO2
- Status last verified
- Mar 2008
- First submitted
- 14 Mar 2008
- Last updated
- 20 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study: Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970
- ClinicalTrials.gov ID
- NCT00639652
- Acronym / sponsor ID
- 16/2008BO2
- Conditions
- Carcinoma, Basal Cell
- Keywords
- Carcinoma, Basal Cell, 3D-histology, Micrographic surgery, Mohs surgery, Shave excision, Recurrence, Esthetic outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Mar 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.
Currently, we conduct a prospective, randomized trial comparing the outcome of surgical excision with the outcome of curettage in nodular and superficial BCCs. Larger BCCs and micronodular or sclerosing BCCs are not included in the randomized study. They are mainly operated using three-dimensional histology (3D-histology, micrographic surgery). In this observational study we measure the cosmetic result and the recurrence rate of all BCCs not included in the randomized trial.
Detailed description
- Disinfection
- Local anesthesia
- Surgery
- Dressing
- Preparation with paraffin for histopathologic evaluation
- Staining with hematoxylin-eosin
- Adjuvant radiotherapy is not applied in any of our patients.
- If histopathology discovers another tumor than BCC, the tumor is excluded.
- If recurrence is suspected, a punch biopsy is taken. If recurrence is confirmed, the endpoint is achieved.
- Patients who provide no feedback receive phone calls.
- The patient receives a letter containing a list of the BCCs treated within the study. She or he is asked to visit the private practitioner with the list after 12 and 48 months (+/- 30 days) referring to the last operation in the recruitment period. The practitioner or the patient return the questionnaire to our department.
- The letter contains a questionnaire about suspicion of recurrence of BCC.
- The patient is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
- The physician is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
- 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
- Meanwhile, the patient has become so ill or high-maintenance that no more follow-up visits can be planned.
- Recurrence of all of the patient's BCCs with histopathologic confirmation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. 3D-histology | – | Procedure: 3D-histologyNodular, micronodular, or sclerosing BCCs |
| 2. Shave excision | – | Procedure: Shave excisionSuperficial BCCs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- BCCs excluded from the randomized trial NCT00515970
Key inclusion criteria (1 listed)
- BCCs excluded from the randomized trial NCT00515970
Key exclusion criteria (1 listed)
- Treatment other than with 3D-histology or shave excision (e.g. deep surgical excision without 3D-histology)
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 |
|---|---|---|
| 3D-histologyAlso: Micrographic surgery, Histographic surgery, Mohs surgeryThe tumor is marked at the 12 o'clock-position. Excision with a safety margin between 2 and 10 mm, depending on tumor size and location. Plastic reconstruction. Removal of the specimen's margins and base as thin layers, using a scalpel. These primarily three-dimensional layers of the specimen's borders are flattened to one level and microscopically screened for tumor cells. 3D-histology is combined with representative vertical sections for histologic diagnosis. Consecutive excisions are performed topographically at the tumor-positive areas and 3D-histology is repeated until tumor-free margins are obtained. | Procedure or surgery | 1. 3D-histology |
| Shave excisionTumor removal by shave excision with a safety margin. Healing by secondary intention. Histologic diagnosis of BCC type (nodular, superficial, morpheaform, micronodular, other type, mixed type) or diagnosis of another tumor than BCC. Comment on complete removal (R0 versus R1). | Procedure or surgery | 2. Shave excision |
Primary outcome
Recurrence of basal cell carcinoma (BCC)
Time frame: Within 4 years after surgery
2 secondary outcomes
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 and 48 months 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: 12 and 48 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2008.
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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
Eberhard Karls University Tuebingen, Department of Dermatology
Kay Brantsch, M.D. principal investigator
Eberhard Karls University Tuebingen, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 1 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 20 Mar 2008. 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 basal cell carcinoma (BCC) (time frame: Within 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 20 Mar 2008.