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

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Completed
• CT.gov ID: NCT03879395
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 108
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Phase
Melanoma Stage Iv; Melanoma Metastatic; Abdominal Tumor	Procedure: Abdominal surgery with metastasectomy

Study Design

• 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: Jan 1, 2010
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Overall survival [December 2018]

   Overall survival

Secondary Outcome Measures

1. Complications according to Clavien-Dindo within 90 days. [90 days]

   Complications according to Clavien-Dindo within 90 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg		Sweden	413 45

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Mar 18, 2019
• Last Update Posted: Jul 7, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Roger Olofsson Bagge, Associate Professor, Senior Consultant Surgeon, Sahlgrenska University Hospital, Sweden: melanoma; abdominal metastasis; metastasectomy; tumor resection; M1c
• Additional relevant MeSH terms: Melanoma; Neoplasm Metastasis; Abdominal Neoplasms

Study Results

No Results Posted as of Jul 7, 2020