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Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study (SurgMelMet)

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: NCT03879395
Recruitment Status : Completed
First Posted : March 18, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden

Study Description
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Brief Summary:

The aim is to conduct a single centre retrospective study of all patients with stage IV melanoma that underwent surgery for metastases at Sahlgrenska University Hospital between 2010-01-01 and 2018-12-31. Pre- and postoperative data will be collected from digital medical records, the Swedish Cancer Registry, the Swedish Cause of Death Register as well as from the national Swedish cancer patient database (INCA). If needed, patient records will be collected from other hospitals. Results will be presented in written format as a summary and analysis of the characteristics of the cases operated on during the inclusion period.

The aim is to identify predictive and prognostic factors for outcome and complications in the surgical treatment of stage IV metastatic melanoma.


Condition or disease Intervention/treatment
Melanoma Stage Iv Melanoma Metastatic Abdominal Tumor Procedure: Abdominal surgery with metastasectomy

Study Design
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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort
Patients with stage IV malignant melanoma with abdominal metastasis (M1c) that underwent abdominal surgery with metastasectomy during the study period.
 Procedure: Abdominal surgery with metastasectomy
Emergency or elective surgery on indications related to abdominally metastasized malignant melanoma


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: December 2018 ]
    Overall survival


Secondary Outcome Measures :
  1. Complications according to Clavien-Dindo within 90 days. [ Time Frame: 90 days ]
    Complications according to Clavien-Dindo within 90 days.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with abdominally metastasized malignant melanoma stage IV.
Criteria

Inclusion Criteria:

  • Biopsy verified stage IV malignant melanoma, stage M1c.
  • Having undergone surgery with metastasectomy of melanoma tumors.

Exclusion Criteria:

  • retroperitoneal tumors
Contacts and Locations
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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): NCT03879395


Locations
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Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Roger Olofsson Bagge, Associate Professor, Senior Consultant Surgeon, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03879395    
Other Study ID Numbers: SurgMelMet
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data to be made available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roger Olofsson Bagge, Sahlgrenska University Hospital, Sweden:
melanoma
abdominal metastasis
metastasectomy
tumor resection
M1c
Additional relevant MeSH terms:
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Melanoma
Neoplasm Metastasis
Abdominal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Neoplasms by Site