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临床试验/NCT02088762
NCT02088762已完成不适用

Impact of the Excision of Melanoma > 2mm in Thickness With 1cm Surgical Margins on Survival of the Patients in Comparison to 2 cm Surgical Margins

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 325 人开始时间: 1997年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
325
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Objective: To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm surgical margins on survival of the patients compared with 2 cm surgical margins.

Background: Early recognition and appropriate excision play a crucial role in management of malignant melanoma, while the size of surrounding normal skin that should be excised is area of controversies.

Methods: The investigators will conduct a retrospective population-based survey in patients with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins in the investigators center. For both groups, the patients' charts reviewed for data including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness, tumor type, presence of ulceration, findings of sentinel nodes, local recurrences, locoregional metastases, disease free survival and overall survival were calculated for both groups.

详细描述

Background

Early recognition and appropriate excision play a crucial role in management of malignant melanoma, while the size of surrounding normal skin that should be excised is area of controversies.

Objective

To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm surgical margins on survival of the patients compared with 2 cm surgical margins.

Methods

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Histologically confirmed melanoma
  • Safety margin 1 cm or 2 cm
  • Tumor thickness according to Breslow >2mm
  • Exclusion Criteria
  • Safety margin less 1 cm
  • Unclear safety margins

排除标准

  • 未提供

结局指标

主要结局

Overall survival

时间窗: Up to 216 months

次要结局

  • Recurrence free survival(Up to 216 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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