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

January 25, 2024 updated by: Roger Olofsson Bagge, Vastra Gotaland Region

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with abdominally metastasized malignant melanoma stage IV.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • retroperitoneal tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: December 2018
Overall survival
December 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications according to Clavien-Dindo within 90 days.
Time Frame: 90 days
Complications according to Clavien-Dindo within 90 days.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SurgMelMet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data to be made available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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