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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088762
• Other study ID #: 24-08-10
• Status: Completed
• Phase: N/A
• First received: March 11, 2014
• Last updated: March 30, 2016
• Start date: January 1997
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Melanoma

Intervention

Procedure:
• surgical excision
comparison of safety margin 1 versus 2 cm

Locations

Country	Name	City	State
Switzerland	Department of Dermatology	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Up to 216 months	No
Secondary	Recurrence free survival		Up to 216 months	No