Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma

Completed

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT02825511
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2015-03-16
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-04
• Study First Posted: 2016-07-07
• Primary Completion: 2019-09-06
• Study Completion: 2019-09-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-13
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2738

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical aggressiveness Score with "Agence Nationale d'Accréditation et d'Evaluation en Santé" (ANAES) criteria	Day 1
Number of the disease according to region (head, leg, arm, eyelid, lip,...)	Day 1

Trial Locations

Locations (17)

University Hospital of Bordeaux - Hospital Saint André; 🇫🇷 Bordeaux, France

Wiart (Dermatologue - Armentieres); 🇫🇷 Armentieres, France

Ruto (Dermatologue - Evreux); 🇫🇷 Evreux, France

Tranchand (Dermatologue - Le Puy En Velay); 🇫🇷 Le Puy En Velay, France

Groupe Hospitalier de L'Institut Catholique de Lille; 🇫🇷 Lille, France

Bacconier (Dermatologue - Marseille); 🇫🇷 Marseille, France

CHU de Nice; 🇫🇷 Nice, France

Chaussade (Dermatologue - Paris); 🇫🇷 Paris, France

Lulin (Dermatologue - Vendome); 🇫🇷 Vendome, France

Tanguy (Dermatologue - Pau); 🇫🇷 PAU, France

Jacquet (Dermatologue - Hyeres); 🇫🇷 Hyeres, France

Dupin (Dermatologue - Auch); 🇫🇷 Auch, France

Will (Dermatologue - Brumath); 🇫🇷 Brumath, France

Bailly (Dermatologue - Toulouse); 🇫🇷 Toulouse, France

Chu de Toulouse; 🇫🇷 Toulouse, France

Haberstroh (Dermatologue - Mulhouse); 🇫🇷 Mulhouse, France

Bolzinger (Dermatologue - Nay); 🇫🇷 NAY, France