Impact of Excision Margins on Survival and Recurrence Rate in Patients With Thick Melanoma (>2mm)

Completed

• Conditions: Melanoma
• Interventions: Procedure: surgical excision

• Registration Number: NCT02088762
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

Detailed Description

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

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.

Study Timeline

• Study Start: 1997-01
• Primary Completion: 2012-12
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Study Completion: 2014-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 cm safety margin	surgical excision	1 cm safety margin
2 cm safety margin	surgical excision	2 cm safety margin

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to 216 months

Secondary Outcome Measures

Name	Time	Method
Recurrence free survival	Up to 216 months

Trial Locations

Locations (1)

Department of Dermatology; 🇨🇭 Bern, Switzerland