Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma

Study Overview
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Brief Summary
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Assessment of the concordance of the initial clinical and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence.

Detailed Description
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The skin cancer is a major public health problem whose incidence is increasing due to the aging population. Among them, basal cell carcinoma (BCC) is a daily concern the dermatologist. The recommendation of good practice for the BCC of support has been established according to French agency methodology in 2004 : Agence Nationale d'Accréditation et d'Evaluation en Santé (ANAES). This classification is based on clinical and pathological use of sometimes mismatched terminology pretending to clinical reality with discrepancies between the clinical appearance and histology. On the other hand the simplified classification of recommendations has never been tested and validated on a large series of BCC. Probabilistic margins applied based on clinical assessment of clinical and pathological subtype, it seems interesting to evaluate the consistency of the initial clinical diagnosis and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence. This study could lead to improved clinical and pathological classification and allow amending the current recommendations of the surgical management of the BCC.

Official Title
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Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years

Conditions
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Basal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primitive BCC BCC clinically suspected or previously biopsied Supports conventional surgical or micrographic techniques. Patient able to sign a consent after reading the briefing note Exclusion Criteria: Recurrent CBC prior medical treatment BCC assigned to another operator for removal Genodermatosis underlying (xeroderma pigmentosum - Gorlin syndrome)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A cohort of basal cell carcinoma<br>A cohort of surgically treated BCC, primitive clinically suspected or previously biopsied on a 4-month period, an expected number of 3 200 cases. The management of the BCC will be consistent with current recommendations. BCC recurrence and those who received prior medical treatment will be excluded. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dimension of basal cell carcinoma. |  | Day 1 | 
| Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform) |  | Day 1 | 
| Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform) |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of the disease according to region (head, leg, arm, eyelid, lip,...) |  | Day 1 | 
| Clinical aggressiveness Score with Agence Nationale d'Accréditation et d'Evaluation en Santé (ANAES) criteria |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma, histological diagnosis, prognostic impact