Actively Recruiting
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Led by Institut Curie · Updated on 2025-09-03
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with uveal melanoma who are at high risk for liver metastases. The study aims to find biomarkers that can help diagnose liver metastases early and tailor follow-up care based on each patient's personalized risk of relapse. This research is designed to improve monitoring and outcomes for these patients over a long period. Participants identified as high risk will undergo regular medical oncology consultations for oncological surveillance following a general disease staging. The study includes liver MRI scans every six months at a specialized center, and for patients who have undergone eye removal (enucleation), blood samples are collected every six months to isolate plasma and mononucleated cells for biomarker research. Blood samples are taken at the first oncology visit, every six months for at least five years and up to ten years, at metastasis diagnosis, and during significant metastatic events such as surgery or changes in treatment response. During the study, participants will have scheduled visits every six months for imaging and blood sampling, with ongoing collection of biological samples for analysis. Researchers will track metastatic events, treatments, and biomarker correlations over up to ten years. This includes studies on lymphocytes, circulating tumor DNA, immune monitoring, and sequencing analyses, along with clinical and imaging data comparisons. The study involves continuous monitoring and evaluation of prognostic biomarkers and patient outcomes throughout the follow-up period.
CONDITIONS
Brief Title
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or older
- Diagnosed with uveal melanoma with high metastatic relapse risk defined by tumor size (T2b/c/d or 6 T3) or chromosome 3 or 8 abnormalities
- Completed treatment of the primary tumor within the last 2 months
- Able to comply with study visit and blood sample schedule
- Signed informed consent form or legal representative consent
You will not qualify if you...
- No French social insurance
- Any social, medical, or psychological condition that makes participation in the research process impossible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical oncology consultation and informed consent
Duration - Up to 10 years
Participants undergo risk-adjusted oncological surveillance including liver MRI scans and blood sample collections for biomarker research.
Liver MRI every 6 months; blood samples taken every 6 months for at least 5 years and up to 10 years for some participants
Duration - Up to 10 years
Participants are monitored at diagnosis of metastasis and during significant events such as surgery or treatment response.
Additional visits as needed at diagnosis of metastasis and significant events
Trial Site Locations
Total: 1 location
1
Institut Curie
Paris, France, 75005
Actively Recruiting
Research Team
S
Sophie Piperno-Neumann, MD
M
Marie-Emmanuelle Legrier, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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