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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Study: Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970|
- Recurrence of basal cell carcinoma (BCC) [ Time Frame: Within 4 years after surgery ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Paraffinized histology blocks and sections.
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Nodular, micronodular, or sclerosing BCCs
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.
2. Shave excision
Procedure: Shave excision
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).
- Local anesthesia
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639652
|Eberhard Karls University, Department of Dermatology|
|Tuebingen, Germany, 72076|
|Study Chair:||Helmut Breuninger, M.D.||Eberhard Karls University Tuebingen, Department of Dermatology|
|Principal Investigator:||Kay Brantsch, M.D.||Eberhard Karls University Tuebingen, Department of Dermatology|