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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
700
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).
Institut Curie
Paris, France
RECRUITINGDescription 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
Time frame: 120 months
Biological study (lymphocytes)
lymphocyte phenotype analysis with biological tests
Time frame: 120 months
Biological study (ctDNA)
circulating tumor DNA analysis with biological tests
Time frame: 120 months
Biological samples prospective collection (ctDNA)
collection of biological samples (circulating tumor DNA analyses)
Time frame: 120 months
Biological samples prospective collection (immune-monitoring analyses)
collection of biological samples (immune-monitoring analyses) with biological tests
Time frame: 120 months
Biological samples prospective collection (sequencing analyses)
collection of biological samples (sequencing analyses) with biological tests
Time frame: 120 months
Comparison of clinical and imaging data (MRI)
Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)
Time frame: 120 months
Comparison of clinical and imaging data (clinical data)
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Comparison of clinical data between the patients with and without identified biomarkers (biological tests)
Time frame: 120 months
Univariate analysis of the prognostic value of identified biomarkers
prognostic value of identified biomarkers analysis with biological tests
Time frame: 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)
Time frame: 120 months
Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes
Analysis of discordant cases regarding genomic/tumor size prognostic factors
Time frame: 120 months