Clinical Trial: Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: University Hospital, Bordeaux

Current Primary Outcome:

  • Dimension of basal cell carcinoma. [ Time Frame: Day 1 ]
  • Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform) [ Time Frame: Day 1 ]
  • Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform) [ Time Frame: Day 1 ]


Original Primary Outcome: Clinical and histological diagnosis of the type of basal cell carcinoma. [ Time Frame: Day 1 ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Localization of the disease [ Time Frame: Day 1 ]
  • Clinical aggressiveness Score with ANAES criteria [ Time Frame: Day 1 ]


Information By: University Hospital, Bordeaux

Dates:
Date Received: July 4, 2016
Date Started: March 2015
Date Completion: November 2018
Last Updated: July 15, 2016
Last Verified: July 2016