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.

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).

Inclusion Criteria:

1. Patient aged of 18 years or more.

2. Patient with uveal melanoma with high metastatic relapse risk defined as :

   • T2b/c/d ou ≥ T3,
   • or chromosom 3 or chromosom 8 abnormality by CGH array.

3. Completion of treatment of the primary tumor ≤ 2 months.

4. Patient able to comply with the schedule of visits and blood samples of the study.

5. Signed informed consent form or legal representative.

Exclusion Criteria:

1. Patient without french social insurance.
2. Any social, medical or psychological condition making the research process impossible.

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).