Clinical Trial: Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Prospective Randomized Trial: Curettage Versus Excision in Nodular and Superficial Basal Cell Carcinomas

Brief Summary:

Basal cell carcinoma (BCC) is the most frequent skin cancer. Uncontrolled growth destroys local anatomic structures. There are various treatment alternatives with different recurrence rates and expenses. After surgical excision, the recurrence rate is in between 3 and 4% and the procedure is relatively expensive. Photodynamic therapy as well as imiquimod 5% are expensive therapies with high recurrence rates, that lack histologic evidence of BCC. Cryosurgery and curettage are inexpensive, although the recurrence rates are higher than after surgical excision.

This prospective, randomized trial compares recurrence rates, cosmetic outcome, and surgery-related complications after curettage versus surgical excision in nodular and superficial BCC. About 600 tumors will be included. One half is treated by curettage, the other half by surgical excision. The follow-up period is four years. If the difference between recurrence rates is ≤7% and the cosmetic outcome as well as the surgery-related complications are not worse after curettage, surgical excision must be considered an overtreatment.

Detailed Summary:

1. First presentation of a patient with clinical or histopathological diagnosis of BCC
2. Study patient number, first and surname, date of birth and gender are listed in a distinct file.
3. Informed consent
4. Whole body screening for skin cancer
5. In- or exclusion of the patient. If the patient is excluded, no more data are obtained.

6. Recording of the following features in an electronic file:

   1. Number of BCCs

   2. Anatomic location

      • Lip
      • Eyelid
      • Ear
      • Nose
      • Other parts of the face
      • Scalp or neck
      • Trunk
      • Arm, hand, or shoulder
      • Leg, foot, or hip

   3. Position

      • Ventral or dorsal. If the tumor is located at the lateral margin of ventral and dorsal, it is considered ventral.
      • Right, left, midline
      • Distinct BCCs are numbered. To ensure future distinction of different tumors, numbering starts with the most up-right-ventral tumor and ends with the most down-left-dorsal one. Numbering continues with BCCs that appear later during the period of recruitment.
      
      Sponsor: University Hospital Tuebingen
      

      Current Primary Outcome: Recurrence of BCC, confirmed by biopsy [ Time Frame: 4 years after surgery ]
      
      

      Original Primary Outcome: recurrence rate [ Time Frame: 4 years ]
      
      

      Current Secondary Outcome:

      • Secondary hemorrhage as remembered by the patient [ Time Frame: 3 months (plus or minus 30 days) after surgery ]
      • Wound infection as remembered by the patient [ Time Frame: 3 months (plus or minus 30 days) after surgery ]
      • Hypesthesia after surgery [ Time Frame: 3 months (plus or minus 30 days) after surgery ]
      • Keloid [ Time Frame: 3 months (plus or minus 30 days) after surgery ]
      • Functional impairment or disfigurement by the scar. Keloid is always a disfiguring scar. If the scar is recognized as keloid, the measure "disfigurement" cannot be used here. [ Time Frame: 3 months (plus or minus 30 days) after surgery ]
      • Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the patient [ Time Frame: 3, 6, 12, 24, 36, and 48 months (plus or minus 30 days) after surgery ]
      • Subjective assessment of the esthetic outcome of the scar on a scale of excellent, good, satisfying, moderate, unfavorable; done by the study physician [ Time Frame: 3, 6, 12, and 48 months (plus or minus 30 days) after surgery ]
      • 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, 24, and 36 months (plus or minus 30 days) after surgery ]
      • Scar length in mm [ Time Frame: 6 and 48 months (plus or minus 30 days) after surgery ]
      • Scar width in mm, perpendicular to its length [ Time Frame: 6 and 48 months (plus or minus 30 days) after surgery ]
      • Color of the scar: hyperpigmented, hypopigmented, or erythematous [ Time Frame: 6 and 48 months (plus or minus 30 days) after surgery ]
      • Level of the scar: atrophic, skin level, hypertrophic, or keloid [ Time Frame: 6 and 48 months (plus or minus 30 days) after surgery ]
      
      
      

      Original Secondary Outcome: complication rate, scarring [ Time Frame: 4 years ]
      
      Information By: University Hospital Tuebingen
      

      Dates:
      Date Received: August 13, 2007
      Date Started: December 2007
      Date Completion: December 2014
      Last Updated: June 14, 2010
      Last Verified: June 2010