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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Uveal Melanoma

Intervention / Treatment
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* Other: Blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged of 18 years or more. 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. Completion of treatment of the primary tumor ≤ 2 months. Patient able to comply with the schedule of visits and blood samples of the study. Signed informed consent form or legal representative. Exclusion Criteria: Patient without french social insurance. Any social, medical or psychological condition making the research process impossible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with uveal melanoma<br> | Other: Blood test<br>* 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).<br>* Other names: MRI in routine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers | metastatic events and treatments reports correlation with their ocrresponding biomarquers | 120 months | 
| Biological studies (lymphocyte phenotype and circulating tumor DNA) | lymphocyte phenotype analysis with biological tests | 120 months | 
| Biological studies (lymphocyte phenotype and circulating tumor DNA) | circulating tumor DNA analysis with biological tests | 120 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) | collection of biological samples (circulating tumor DNA analyses) | 120 months | 
| Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) | collection of biological samples (immune-monitoring analyses) with biological tests | 120 months | 
| Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) | collection of biological samples (sequencing analyses) with biological tests | 120 months | 
| Comparison of clinical and imaging data between the patients with and without identified biomarkers | Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests) | 120 months | 
| Comparison of clinical and imaging data between the patients with and without identified biomarkers | Comparison of clinical data (medical patients records) between the patients with and without identified biomarkers (biological tests) | 120 months | 
| Univariate analysis of the prognostic value of identified biomarkers | prognostic value of identified biomarkers analysis with biological tests | 120 months | 
| Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data | Multivariate analysis of the prognostic value of identifies biomarkers (biological tests) adjusted for clinical (medical patients records) and imaging data (MRI) | 120 months | 
| Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes | Analysis of discordant cases regarding genomic/tumor size prognostic factors | 120 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uveal melanoma