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

NCT ID: NCT02088762

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1 cm safety margin

1 cm safety margin

surgical excision

Intervention Type PROCEDURE

comparison of safety margin 1 versus 2 cm

2 cm safety margin

2 cm safety margin

surgical excision

Intervention Type PROCEDURE

comparison of safety margin 1 versus 2 cm

Interventions

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surgical excision

comparison of safety margin 1 versus 2 cm

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert E Hunger, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University of Bern

Locations

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Department of Dermatology

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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24-08-10

Identifier Type: -

Identifier Source: org_study_id

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