Melanoma Stage IvSurgMelMetNCT03879395
Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study
An observational study of Melanoma Stage Iv and Melanoma Metastatic, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage Iv, Melanoma Metastatic, Abdominal Tumor
- What is being tested?
- Abdominal surgery with metastasectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2010to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with abdominally metastasized malignant melanoma stage IV.
Who may be able to join
- Biopsy verified stage IV malignant melanoma, stage M1c.
- Having undergone surgery with metastasectomy of melanoma tumors.
Who cannot join
- retroperitoneal tumors
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Melanoma Stage Iv, Melanoma Metastatic, Abdominal Tumor
- Being tested
- Abdominal surgery with metastasectomy
- Keywords
- melanoma, abdominal metastasis, metastasectomy, tumor resection, M1c
- Medical subject headings
- Melanoma, Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal surgery with metastasectomyProcedure or surgery
Emergency or elective surgery on indications related to abdominally metastasized malignant melanoma
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients with stage IV malignant melanoma with abdominal metastasis (M1c) that underwent abdominal surgery with metastasectomy during the study period. Receives: Procedure: Abdominal surgery with metastasectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: December 2018
Secondary outcomes (1)
Complications according to Clavien-Dindo within 90 days.
Complications according to Clavien-Dindo within 90 days.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Jan 2010
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma Stage IvStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roger Olofsson Bagge, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879395
- Sponsor's protocol ID
- SurgMelMet
- Acronym
- SurgMelMet
- Status last verified
- Jan 2024
- First submitted
- 15 Mar 2019
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data to be made available upon request.
Publications
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.
PubMed 31299988
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03879395
- Acronym / sponsor ID
- SurgMelMet / SurgMelMet
- Conditions
- Melanoma Stage Iv, Melanoma Metastatic, Abdominal Tumor
- Keywords
- melanoma, abdominal metastasis, metastasectomy, tumor resection, M1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Procedure: Abdominal surgery with metastasectomyPatients with stage IV malignant melanoma with abdominal metastasis (M1c) that underwent abdominal surgery with metastasectomy during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominally metastasized malignant melanoma stage IV.
Key inclusion criteria (2 listed)
- Biopsy verified stage IV malignant melanoma, stage M1c.
- Having undergone surgery with metastasectomy of melanoma tumors.
Key exclusion criteria (1 listed)
- retroperitoneal tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal surgery with metastasectomyEmergency or elective surgery on indications related to abdominally metastasized malignant melanoma | Procedure or surgery | Cohort |
Primary outcome
Overall survival
Time frame: December 2018
Overall survival
1 secondary outcome
Complications according to Clavien-Dindo within 90 days.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 31299988Holmberg 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.
- Individual participant dataSharing planned: Undecided. Data to be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Stage Iv and Melanoma Metastatic, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: December 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.