Uveal Melanoma
Conditions
Keywords
uveal melanoma
Brief summary
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
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).
Interventions
OTHERBlood 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).
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers | 120 months | metastatic events and treatments reports correlation with their ocrresponding biomarquers |
| Biological study (lymphocytes) | 120 months | lymphocyte phenotype analysis with biological tests |
| Biological study (ctDNA) | 120 months | circulating tumor DNA analysis with biological tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of clinical and imaging data (MRI) | 120 months | Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests) |
| Comparison of clinical and imaging data (clinical data) | 120 months | Comparison of clinical data between the patients with and without identified biomarkers (biological tests) |
| Biological samples prospective collection (ctDNA) | 120 months | collection of biological samples (circulating tumor DNA analyses) |
| Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data | 120 months | Multivariate analysis of the prognostic value of identifies biomarkers (biological tests) adjusted for clinical (medical patients records) and imaging data (MRI) |
| Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes | 120 months | Analysis of discordant cases regarding genomic/tumor size prognostic factors |
| Univariate analysis of the prognostic value of identified biomarkers | 120 months | prognostic value of identified biomarkers analysis with biological tests |
| Biological samples prospective collection (immune-monitoring analyses) | 120 months | collection of biological samples (immune-monitoring analyses) with biological tests |
| Biological samples prospective collection (sequencing analyses) | 120 months | collection of biological samples (sequencing analyses) with biological tests |
Countries
France
Contacts
Primary ContactSophie Piperno-Neumann, MD
Backup ContactMarie-Emmanuelle Legrier, PhD
Outcome results
None listed