Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma (CAC-CBC)

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

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

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma

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 Type: Observational
• Enrollment (Actual): 2738

Contacts and Locations

Study Locations

• France
  • Armentieres, France, 59280
    • Wiart (Dermatologue - Armentieres)
  • Auch, France, 32000
    • Dupin (Dermatologue - Auch)
  • Bordeaux, France, 33000
    • University Hospital of Bordeaux - Hospital Saint André
  • Brumath, France, 67170
    • Will (Dermatologue - Brumath)
  • Evreux, France, 27000
    • Ruto (Dermatologue - Evreux)
  • Hyeres, France, 83400
    • Jacquet (Dermatologue - Hyeres)
  • Le Puy En Velay, France, 43000
    • Tranchand (Dermatologue - Le Puy En Velay)
  • Lille, France, 51000
    • Groupe Hospitalier de l'Institut Catholique de Lille
  • Marseille, France, 130005
    • Bacconier (Dermatologue - Marseille)
  • Mulhouse, France, 68100
    • Haberstroh (Dermatologue - Mulhouse)
  • NAY, France, 64800
    • Bolzinger (Dermatologue - Nay)
  • Nice, France, 06000
    • CHU de Nice
  • PAU, France, 64000
    • Tanguy (Dermatologue - Pau)
  • Paris, France, 75000
    • Chaussade (Dermatologue - Paris)
  • Toulouse, France, 31000
    • CHU de TOULOUSE
  • Toulouse, France, 31000
    • Bailly (Dermatologue - Toulouse)
  • Vendome, France, 41100
    • Lulin (Dermatologue - Vendome)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

BCC primitive, clinically suspected or previously biopsied

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Société de Dermatologie Française
• Investigators: Principal Investigator: Jean Michel AMICI, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2015
• Primary Completion (Actual): September 6, 2019
• Study Completion (Actual): September 6, 2019

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: basal cell carcinoma, histological diagnosis, prognostic impact
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell
• Other Study ID Numbers: CHUBX 2014/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No