NCT03879395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

9 years

First QC Date

March 15, 2019

Last Update Submit

January 25, 2024

Conditions

Keywords

melanomaabdominal metastasismetastasectomytumor resectionM1c

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival

    December 2018

Secondary Outcomes (1)

  • Complications according to Clavien-Dindo within 90 days.

    90 days

Study Arms (1)

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

Interventions

Emergency or elective surgery on indications related to abdominally metastasized malignant melanoma

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with abdominally metastasized malignant melanoma stage IV.

You may qualify if:

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

You may not qualify if:

  • retroperitoneal tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

  • Holmberg CJ, Alwan G, Ny L, Olofsson Bagge R, Katsarelias D. Surgery for gastrointestinal metastases of malignant melanoma - a retrospective exploratory study. World J Surg Oncol. 2019 Jul 12;17(1):123. doi: 10.1186/s12957-019-1663-z.

MeSH Terms

Conditions

MelanomaAbdominal Neoplasms

Interventions

Metastasectomy

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Senior Consultant Surgeon

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 18, 2019

Study Start

January 1, 2010

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 26, 2024

Record last verified: 2024-01

Locations