Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma

NCT ID: NCT02825511

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2738 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-16
• Study Completion Date: 2019-09-06

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.

Conditions

Basal Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A cohort of basal cell carcinoma

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.

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société de Dermatologie Française

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Michel AMICI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Wiart (Dermatologue - Armentieres)

Armentières, , France

Dupin (Dermatologue - Auch)

Auch, , France

University Hospital of Bordeaux - Hospital Saint André

Bordeaux, , France

Will (Dermatologue - Brumath)

Brumath, , France

Ruto (Dermatologue - Evreux)

Évreux, , France

Jacquet (Dermatologue - Hyeres)

Hyères, , 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

Haberstroh (Dermatologue - Mulhouse)

Mulhouse, , France

Bolzinger (Dermatologue - Nay)

Nay, , France

CHU de Nice

Nice, , France

Chaussade (Dermatologue - Paris)

Paris, , France

Tanguy (Dermatologue - Pau)

Pau, , France

Bailly (Dermatologue - Toulouse)

Toulouse, , France

Chu de Toulouse

Toulouse, , France

Lulin (Dermatologue - Vendome)

Vendôme, , France

Countries

France

Other Identifiers

CHUBX 2014/18

Identifier Type: -

Identifier Source: org_study_id