Official Title
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Brief Title
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Protocol ID
NCT04424719
Lead Sponsor
Institut Curie
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).
Study Period
-
Enrollment Count
700 participants
Eligibility Criteria
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.
Filters
Uveal Melanoma
NA
RECRUITING
ADULT
OLDER_ADULT