Impact of Excision Margins on Survival and Recurrence Rate in Patients With Thick Melanoma (>2mm)
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
1 other identifier
observational
325
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 1997
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 11, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 31, 2016
March 1, 2016
15.9 years
March 11, 2014
March 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Up to 216 months
Secondary Outcomes (1)
Recurrence free survival
Up to 216 months
Study Arms (2)
1 cm safety margin
1 cm safety margin
2 cm safety margin
2 cm safety margin
Interventions
comparison of safety margin 1 versus 2 cm
Eligibility Criteria
Patient with melanom of a tumourthickness above 2 mm admitted to the University Hospital of Bern, Inselspital
You may qualify if:
- Histologically confirmed melanoma
- Safety margin 1 cm or 2 cm
- Tumor thickness according to Breslow \>2mm
You may not qualify if:
- Safety margin less 1 cm
- Unclear safety margins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology
Bern, 3012, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert E Hunger, MD-PhD
Department of Dermatology, University of Bern
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2014
First Posted
March 17, 2014
Study Start
January 1, 1997
Primary Completion
December 1, 2012
Study Completion
December 1, 2014
Last Updated
March 31, 2016
Record last verified: 2016-03