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

March 30, 2016 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with melanom of a tumourthickness above 2 mm admitted to the University Hospital of Bern, Inselspital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 cm safety margin
Procedure: surgical excision
comparison of safety margin 1 versus 2 cm
2 cm safety margin
Procedure: surgical excision
comparison of safety margin 1 versus 2 cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 216 months
Up to 216 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence free survival
Time Frame: Up to 216 months
Up to 216 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Robert E Hunger, MD-PhD, Department of Dermatology, University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 17, 2014

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-08-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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