Clinical trial NCT00639652: Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970
Official title: Observational Study: Recurrence Rate and Esthetic Outcome After Excision of Basal Cell Carcinomas Excluded From Trial NCT00515970
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Basal Cell
Keywords: Carcinoma, Basal Cell
3D-histology
Micrographic surgery
Mohs surgery
Shave excision
Recurrence
Esthetic outcome
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: BCCs excluded from the randomized trial NCT00515970

Brief 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. 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: 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 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)

Primary outcomes:
measure: Recurrence of basal cell carcinoma (BCC)
timeFrame: Within 4 years after surgery
Secondary outcomes:
measure: Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by a private practitioner.
timeFrame: 12 and 48 months after surgery
measure: Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the patient.
timeFrame: 12 and 48 months after surgery
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Eberhard Karls University, Department of Dermatology
Study officials:
affiliation: Eberhard Karls University Tuebingen, Department of Dermatology
name: Helmut Breuninger, M.D.
role: STUDY_CHAIR
affiliation: Eberhard Karls University Tuebingen, Department of Dermatology
name: Kay Brantsch, M.D.
role: PRINCIPAL_INVESTIGATOR
References: