Clinical trial NCT02825511: Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma
Official title: Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Keywords: basal cell carcinoma, histological diagnosis, prognostic impact
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Société de Dermatologie Française
First posted: 2016-07-07
Enrollment: 2738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BCC primitive, clinically suspected or previously biopsied

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.

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)

Primary outcomes:
measure: Dimension of basal cell carcinoma.
timeFrame: Day 1
measure: Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform)
timeFrame: Day 1
measure: Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform)
timeFrame: Day 1
Secondary outcomes:
measure: Number of the disease according to region (head, leg, arm, eyelid, lip,...)
timeFrame: Day 1
measure: Clinical aggressiveness Score with "Agence Nationale d'Accréditation et d'Evaluation en Santé" (ANAES) criteria
timeFrame: Day 1
Other outcomes:
Locations:
city: Armentieres
country: France
facility: Wiart (Dermatologue - Armentieres)
city: Auch
country: France
facility: Dupin (Dermatologue - Auch)
city: Bordeaux
country: France
facility: University Hospital of Bordeaux - Hospital Saint André
city: Brumath
country: France
facility: Will (Dermatologue - Brumath)
city: Evreux
country: France
facility: Ruto (Dermatologue - Evreux)
city: Hyeres
country: France
facility: Jacquet (Dermatologue - Hyeres)
city: Le Puy En Velay
country: France
facility: Tranchand (Dermatologue - Le Puy En Velay)
city: Lille
country: France
facility: Groupe Hospitalier de L'Institut Catholique de Lille
city: Marseille
country: France
facility: Bacconier (Dermatologue - Marseille)
city: Mulhouse
country: France
facility: Haberstroh (Dermatologue - Mulhouse)
city: NAY
country: France
facility: Bolzinger (Dermatologue - Nay)
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Chaussade (Dermatologue - Paris)
city: PAU
country: France
facility: Tanguy (Dermatologue - Pau)
city: Toulouse
country: France
facility: Bailly (Dermatologue - Toulouse)
city: Toulouse
country: France
facility: Chu de Toulouse
city: Vendome
country: France
facility: Lulin (Dermatologue - Vendome)
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean Michel AMICI, MD
role: PRINCIPAL_INVESTIGATOR
References: