Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Basal Cell Carcinoma
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 2738
- Locations
- 17
- Primary Endpoint
- Dimension of basal cell carcinoma.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Dimension of basal cell carcinoma.
Time Frame: Day 1
Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform)
Time Frame: Day 1
Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform)
Time Frame: Day 1
Secondary Outcomes
- 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)