SALOME: A Personalized Monitoring Plan to Catch Uveal Melanoma Spread Early
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
In Plain English
This study is designed to help doctors catch uveal melanoma before it spreads to your liver—the most common place this cancer goes. Instead of using a one-size-fits-all approach, the SALOME study creates a personalized monitoring plan based on YOUR specific risk of the cancer coming back. If you're at high risk, you'll be followed more closely than patients at lower risk. Here's what being in the study means: You'll have liver MRI scans (detailed pictures of your liver) every 6 months to look for any early signs of spread. If your eye was removed (enucleation), you'll also give small blood samples every 6 months for at least 5 years. These blood samples aren't for treatment—they're for researchers to study special markers (like a cellular fingerprint) that might help predict who's most likely to have cancer return. This information could help doctors catch problems earlier and adjust your care plan as needed. The goal is simple: catch any spread as early as possible when treatment options are better, and give you peace of mind with a monitoring schedule tailored to your actual risk level.
What This Trial Does
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.
How It Works
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 disease (surgery, treatment response or progression).
Who Can Join
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
Blood test (OTHER)
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).