Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088762
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment
Melanoma Procedure: surgical excision

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 325 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : January 1997
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

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

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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 216 months ]

Secondary Outcome Measures :
  1. Recurrence free survival [ Time Frame: Up to 216 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with melanom of a tumourthickness above 2 mm admitted to the University Hospital of Bern, Inselspital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088762


Locations
Layout table for location information
Switzerland
Department of Dermatology
Bern, Switzerland, 3012
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Layout table for investigator information
Principal Investigator: Robert E Hunger, MD-PhD Department of Dermatology, University of Bern
Layout table for additonal information
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02088762    
Other Study ID Numbers: 24-08-10
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Keywords provided by University Hospital Inselspital, Berne:
margin of safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas