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RECRUITINGINTERVENTIONAL

Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form or legal representative. Who Should NOT Join This Trial: 1. Patient without french social insurance. 2. Any social, medical or psychological condition making the research process impossible. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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).

Locations (1)

Institut Curie
Paris, France