Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00639652
First received: March 14, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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
Carcinoma, Basal Cell
Procedure: 3D-histology
Procedure: Shave excision

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Recurrence of basal cell carcinoma (BCC) [ Time Frame: Within 4 years after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


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
1. 3D-histology
Nodular, micronodular, or sclerosing BCCs
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.
Other Names:
  • Micrographic surgery
  • Histographic surgery
  • Mohs surgery
2. Shave excision
Superficial BCCs
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).

Detailed Description:
  1. Disinfection
  2. Local anesthesia
  3. Surgery
  4. Dressing
  5. Preparation with paraffin for histopathologic evaluation
  6. Staining with hematoxylin-eosin
  7. Adjuvant radiotherapy is not applied in any of our patients.
  8. If histopathology discovers another tumor than BCC, the tumor is excluded.
  9. If recurrence is suspected, a punch biopsy is taken. If recurrence is confirmed, the endpoint is achieved.
  10. Patients who provide no feedback receive phone calls.
  11. 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.
  12. The letter contains a questionnaire about suspicion of recurrence of BCC.
  13. The patient is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
  14. The physician is asked to assess the esthetic outcome on a scale of excellent, good, satisfactory, mediocre, and poor.
  15. When follow-up is closed for an individual patient, the reason is recorded:

    1. Planned end of follow-up after 48 months
    2. Patient has moved.
    3. Death (date of death)
    4. Consent withdrawn
    5. Meanwhile, the patient has become so ill or high-maintenance that no more follow-up visits can be planned.
    6. Recurrence of all of the patient's BCCs with histopathologic confirmation.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

BCCs excluded from the randomized trial NCT00515970

Criteria

Inclusion Criteria:

  • BCCs excluded from the randomized trial NCT00515970

Exclusion Criteria:

  • Treatment other than with 3D-histology or shave excision (e.g. deep surgical excision without 3D-histology)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639652

Locations
Germany
Eberhard Karls University, Department of Dermatology
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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
  More Information

No publications provided

Responsible Party: Helmut Breuninger, Department of Dermatology, Eberhard Karls University
ClinicalTrials.gov Identifier: NCT00639652     History of Changes
Other Study ID Numbers: 16/2008BO2
Study First Received: March 14, 2008
Last Updated: March 14, 2008
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University Hospital Tuebingen:
Carcinoma, Basal Cell
3D-histology
Micrographic surgery
Mohs surgery
Shave excision
Recurrence
Esthetic outcome

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014