NCT00639652

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 20, 2008

Status Verified

March 1, 2008

Enrollment Period

6 years

First QC Date

March 14, 2008

Last Update Submit

March 14, 2008

Conditions

Carcinoma, Basal Cell

Keywords

Carcinoma, Basal Cell3D-histologyMicrographic surgeryMohs surgeryShave excisionRecurrenceEsthetic outcome

Outcome Measures

Primary Outcomes (1)

  • Recurrence of basal cell carcinoma (BCC)

    Within 4 years after surgery

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

1. 3D-histology

Nodular, micronodular, or sclerosing BCCs

Procedure: 3D-histology

2. Shave excision

Superficial BCCs

Procedure: Shave excision

Interventions

3D-histologyPROCEDURE

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.

Also known as: Micrographic surgery, Histographic surgery, Mohs surgery
1. 3D-histology
Shave excisionPROCEDURE

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).

2. Shave excision

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

BCCs excluded from the randomized trial NCT00515970

You may qualify if:

  • BCCs excluded from the randomized trial NCT00515970

You may not qualify if:

  • Treatment other than with 3D-histology or shave excision (e.g. deep surgical excision without 3D-histology)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eberhard Karls University, Department of Dermatology

Tübingen, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Paraffinized histology blocks and sections.

MeSH Terms

Conditions

Carcinoma, Basal CellRecurrence

Interventions

Mohs Surgery

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MicrosurgerySurgical Procedures, OperativeDermatologic Surgical ProceduresPlastic Surgery Procedures

Study Officials

  • Helmut Breuninger, M.D.

    Eberhard Karls University Tuebingen, Department of Dermatology

    STUDY CHAIR

  • Kay Brantsch, M.D.

    Eberhard Karls University Tuebingen, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2008

First Posted

March 20, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 20, 2008

Record last verified: 2008-03

Locations

DE(1)