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

Carcinoma, Basal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00639652
• Other study ID #: 16/2008BO2
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 14, 2008
• Last updated: March 14, 2008
• Start date: December 2007
• Est. completion date: December 2013

Study information

• Verified date: March 2008
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Recurrence

Intervention

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.
• 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).

Locations

Country	Name	City	State
Germany	Eberhard Karls University, Department of Dermatology	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of basal cell carcinoma (BCC)		Within 4 years after surgery	Yes
Secondary	Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by a private practitioner.		12 and 48 months after surgery	No
Secondary	Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the patient.		12 and 48 months after surgery	No