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临床试验/NCT02825511
NCT02825511已完成不适用

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

University Hospital, Bordeaux17 个研究点 分布在 1 个国家目标入组 2,738 人开始时间: 2015年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,738
试验地点
17
主要终点
Dimension of basal cell carcinoma.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Recurrent CBC
  • prior medical treatment
  • BCC assigned to another operator for removal
  • Genodermatosis underlying (xeroderma pigmentosum - Gorlin syndrome)

结局指标

主要结局

Dimension of basal cell carcinoma.

时间窗: Day 1

Number of clinical type of basal cell carcinoma (nodular, superficial or sclerodermiform)

时间窗: Day 1

Number of histological type of basal cell carcinoma (nodular, superficial, infiltrating or sclerodermiform)

时间窗: Day 1

次要结局

  • 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)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (17)

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