Basal Cell Carcinoma Clinical Trial
Official title:
Clinical Diagnosis Versus Histological Diagnosis by Punch Biopsy to Determine the Subtype of Basal Cell Carcinoma
Skin cancer is the most common cancer in Caucasians. Basal cell carcinoma (BCC) is the most
frequent skin cancer with around 44.000 new tumours per year in the Netherlands, and its
incidence is still rising. Prior to treatment, a punch biopsy (PB) is taken from the
suspected lesion, in order to determine the subtype of BCC. There are three different
histological subtypes of BCC, from least to most aggressive: superficial, nodular and
aggressive. Based on the most aggressive subtype seen in the PB, a suitable surgical margin
is chosen. Surgical excision (SE) is the treatment of first choice in all BCC subtypes
according to the Dutch guidelines. Recent developments of non-invasive therapies for
superficial BCC might be the first choice of treatment in the future. These non-invasive
treatments (photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU)) have better
cosmetic results than SE and are therefore also used in the Maastricht University Medical
Center. Drawback is a higher recurrence rate than SE. As nodular and aggressive subtypes
grow deeper into the dermis, they have to be treated with SE with a 3 mm and 5 mm margin
respectively. If BCC are located in the H-zone, the treatment will be Mohs micrographic
surgery (MMS). Unfortunately, 30% of subtypes seen in the PB do not correspond with the
subtype seen in the subsequent SE/MMS. The consequence is overtreatment and undertreatment.
A potential better or equal way to determine the BCC subtype might be the clinical
diagnosis. To our knowledge, there is no literature about the diagnostic value of the
clinical diagnosis to determine the subtype of BCC seen in the SE/MMS specimen. We want to
confirm the hypothesis that the clinical diagnosis is as good as, or even better than the
histological diagnosis by PB to determine the BCC subtype in the subsequent SE/MMS. In this
case, patients don't have to undergo an extra procedure, diagnostic route is shortened.
- Primary objective: to establish the observed agreement of clinical diagnosis compared to
histological diagnosis by to determine the most aggressive subtype of BCC
- Secondary objectives: inter-observer and intra-observer variability of dermatologists and
pathologists to determine subtype BCC.
Status | Completed |
Enrollment | 150 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients aged 18 years or older, otherwise healthy, with = three primary (no previous treatment) clinically determined BCC will be recruited for this study. Exclusion Criteria: - Patients using immunosuppressive drugs. Genetic skin cancer disorders. Earlier treatments at the same site. Age under 18 years. More than 3 clinical suspected BCCs. Not capable of informed consent. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Netherlands | Erasmus Medical Centre Rotterdam | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic value of clinical diagnosis | The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour. | Within 24 hours after the patient presents at the outpatient department of dermatology | No |
Primary | Diagnostic value of punch biopsy | The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour. | Histology within 2-3 weeks after the clinical diagnosis | No |
Primary | Diagnostic value of the surgical excision (SE)/ Mohs micrographic surgery (MMS) | The current proposal aims at establishing the observed agreement of the clinical diagnosis to and histological diagnosis to detect the most aggressive BCC subtype of the entire tumour. | Within 1 month after the punch biopsy | No |
Secondary | Interobserver and intraobserver variability | To assess the inter-observer and intra-observer variability of dermatologists and pathologists to determine subtype BCC. | After clinical diagnosis, punch biopsy and surgical excision have been performed | No |
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