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Sponsored by: |
University Hospital Tuebingen |
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Information provided by: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT00639652 |
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.
Condition | Intervention |
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Carcinoma, Basal Cell |
Procedure: 3D-histology Procedure: Shave excision |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Observational Study: Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970 |
Paraffinized histology blocks and sections.
Estimated Enrollment: | 800 |
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) |
Groups/Cohorts | Assigned Interventions |
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1. 3D-histology
Nodular, micronodular, or sclerosing BCCs
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Procedure: 3D-histology
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.
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2. Shave excision
Superficial BCCs
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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).
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When follow-up is closed for an individual patient, the reason is recorded:
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
BCCs excluded from the randomized trial NCT00515970
Inclusion Criteria:
Exclusion Criteria:
Germany | |
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 |
Responsible Party: | Department of Dermatology, Eberhard Karls University ( Helmut Breuninger ) |
Study ID Numbers: | 16/2008BO2 |
Study First Received: | March 14, 2008 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00639652 History of Changes |
Health Authority: | Germany: Federal Ministry of Education and Research |
Carcinoma, Basal Cell 3D-histology Micrographic surgery Mohs surgery |
Shave excision Recurrence Esthetic outcome |
Neoplasms, Basal Cell Carcinoma, Basal Cell Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Disease Attributes Neoplasms Pathologic Processes Neoplasms by Histologic Type Neoplasms, Basal Cell |
Carcinoma, Basal Cell Recurrence Neoplasms, Glandular and Epithelial Carcinoma |