Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

— CAC-CBC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825511
• Other study ID #: CHUBX 2014/18
• Status: Completed
• Start date: March 16, 2015
• Est. completion date: September 6, 2019

Study information

• Verified date: October 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2738
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Locations

Country	Name	City	State
France	Wiart (Dermatologue - Armentieres)	Armentieres
France	Dupin (Dermatologue - Auch)	Auch
France	University Hospital of Bordeaux - Hospital Saint André	Bordeaux
France	Will (Dermatologue - Brumath)	Brumath
France	Ruto (Dermatologue - Evreux)	Evreux
France	Jacquet (Dermatologue - Hyeres)	Hyeres
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)	Vendome

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Société de Dermatologie Française

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dimension of basal cell carcinoma.		Day 1
Primary	Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform)		Day 1
Primary	Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform)		Day 1
Secondary	Number of the disease according to region (head, leg, arm, eyelid, lip,...)		Day 1
Secondary	Clinical aggressiveness Score with "Agence Nationale d'Accréditation et d'Evaluation en Santé" (ANAES) criteria		Day 1