Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02825511

Acronym

CAC-CBC

Enrollment

2738

Registered

2016-07-07

Start date

2015-03-16

Completion date

2019-09-06

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinoma, histological diagnosis, prognostic impact

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

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

Countries

France

Outcome results