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NCT03879395 Clinical Trial

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

Melanoma Stage Iv Clinical Trial

— SurgMelMet  

Official title:
Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03879395
Other study ID # SurgMelMet
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2018

Study information
Verified date January 2024
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Biopsy verified stage IV malignant melanoma, stage M1c. - Having undergone surgery with metastasectomy of melanoma tumors. Exclusion Criteria: - retroperitoneal tumors

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Abdominal surgery with metastasectomy
Emergency or elective surgery on indications related to abdominally metastasized malignant melanoma

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Overall survival December 2018
Secondary Complications according to Clavien-Dindo within 90 days. Complications according to Clavien-Dindo within 90 days. 90 days
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