Melanoma Surgery
Conditions
Brief summary
Histopathological confirmed relapse, defined as either local, regional (in transit or lymph node) or systemic relapses. Systemic metastases suspected on PET / CT/ MR will be used if a biopsy is not possible. We will calculate relapse risk proportions for each treatment arm as a binary outcome.
Detailed description
Adverse events, summarised according to grade: Mild: defined as the patient’s report of abdominal pain, diarrhoea or nausea. Severe: thromboembolic events, verified radiologically., Postoperative complications, summarised according to the type and postoperative timepoint, is defined as binary outcomes as bleeding, seroma or infection, Melanoma specific survival: defined as the period from the date of surgery (wide local excision and sentinel lymph node biopsy) to the date of death from suspected systemic melanoma (histopathological confirmed relapse or systemic metastases suspected on PET / CT / MR) or the date of completed 5 years follow-up., Overall survival: defined as the period from the date of surgery (re-excision and sentinel node) to the date of death from all causes or the date of finalised 5 years follow-up., Relapse free survival: defined as the period from the date of surgery (re-excision and sentinel node) to the date of histopathological confirmed relapse (local, regional or systemic), death from all causes or the data or completed 2 years follow-up.
Interventions
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histopathological confirmed relapse, defined as either local, regional (in transit or lymph node) or systemic relapses. Systemic metastases suspected on PET / CT/ MR will be used if a biopsy is not possible. We will calculate relapse risk proportions for each treatment arm as a binary outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, summarised according to grade: Mild: defined as the patient’s report of abdominal pain, diarrhoea or nausea. Severe: thromboembolic events, verified radiologically., Postoperative complications, summarised according to the type and postoperative timepoint, is defined as binary outcomes as bleeding, seroma or infection, Melanoma specific survival: defined as the period from the date of surgery (wide local excision and sentinel lymph node biopsy) to the date of death from suspected systemic melanoma (histopathological confirmed relapse or systemic metastases suspected on PET / CT / MR) or the date of completed 5 years follow-up., Overall survival: defined as the period from the date of surgery (re-excision and sentinel node) to the date of death from all causes or the date of finalised 5 years follow-up., Relapse free survival: defined as the period from the date of surgery (re-excision and sentinel node) to the date of histopathological confirmed relapse (local, regional | — |
Countries
Denmark
Outcome results
None listed