Clinical trial NCT02088762: Impact of Excision Margins on Survival and Recurrence Rate in Patients With Thick Melanoma (>2mm)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: margin of safety
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 325
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with melanom of a tumourthickness above 2 mm admitted to the University Hospital of Bern, Inselspital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Up to 216 months
Secondary outcomes:
measure: Recurrence free survival
timeFrame: Up to 216 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Dermatology
Study officials:
affiliation: Department of Dermatology, University of Bern
name: Robert E Hunger, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: