An interventional study of Blood test in Uveal Melanoma, sponsored by Institut Curie. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Institut Curie · Not applicable, Interventional, and Health services research
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.
102 studies on the registry are indexed under Uveal Melanoma; 37 are open to participants now.
This study's planned enrollment of 700 is above the median of 41 across 92 interventional studies indexed under Uveal Melanoma.
Browse Uveal Melanoma studies →Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with uveal melanoma with high metastatic relapse risk defined as :
Exclusion Criteria:
High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. For enucleated patients, a blood sample is required according to the study schedule.
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).
Also known as: MRI in routine
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
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)
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
Plan to share: Yes — Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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