Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)

Institut Curie

Status: Enrolling

Conditions: Uveal Melanoma

Treatments: Other: Blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT04424719

IC2019-13

Details and patient eligibility

About

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.

Full 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).

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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700 participants in 1 patient group

Patients with uveal melanoma

Other group

Description:

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.

Treatment:

Other: Blood test