Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
NCT04424719 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700
Last updated 2025-09-03
Summary
Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.
Conditions
Interventions
- OTHER
-
Blood test
High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule : (i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines). (ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research. * M0 : during the first medical oncology visit. * At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120). * At the diagnosis of metastasis. * At each significant event during the metastatic disease (surgery, treatment response or progression).
Sponsors & Collaborators
-
Institut Curie
lead OTHER
Principal Investigators
-
Sophie Piperno-Neumann, MD · Institut Curie
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-08
- Primary Completion
- 2037-07-07
- Completion
- 2037-07-07
Countries
- France
Study Locations
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