Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma (CAC-CBC)
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|ClinicalTrials.gov Identifier: NCT02825511|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : October 14, 2020
|Condition or disease|
|Basal Cell Carcinoma|
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|
|Actual Enrollment :||2738 participants|
|Official Title:||Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years|
|Actual Study Start Date :||March 16, 2015|
|Actual Primary Completion Date :||September 6, 2019|
|Actual Study Completion Date :||September 6, 2019|
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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825511
|Principal Investigator:||Jean Michel AMICI, MD||University Hospital, Bordeaux|