Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
NCT ID: NCT04424719
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
700 participants
INTERVENTIONAL
2020-07-08
2037-07-07
Brief Summary
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Detailed Description
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(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).
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Patients with uveal melanoma
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.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Any social, medical or psychological condition making the research process impossible.
18 Years
ALL
No
Sponsors
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Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Sophie Piperno-Neumann, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie
Locations
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Institut Curie
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IC2019-13
Identifier Type: -
Identifier Source: org_study_id
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