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

Not Applicable

Recruiting

• Conditions: Uveal Melanoma
• Interventions: Other: Blood test

• Registration Number: 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 Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-11
• Study Start: 2020-07-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2035-07-26
• Study Completion: 2035-07-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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.

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Exclusion Criteria

1. Patient without french social insurance.
2. Any social, medical or psychological condition making the research process impossible.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with uveal melanoma	Blood test	-

Primary Outcome Measures

Name	Time	Method
Biological studies (lymphocyte phenotype and circulating tumor DNA)	120 months	circulating tumor DNA analysis with biological tests
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

Secondary Outcome Measures

Name	Time	Method
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)
Univariate analysis of the prognostic value of identified biomarkers	120 months	prognostic value of identified biomarkers analysis with biological tests
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)	120 months	collection of biological samples (sequencing analyses) with biological tests
Comparison of clinical and imaging data between the patients with and without identified biomarkers	120 months	Comparison of clinical data (medical patients records) between the patients with and without identified biomarkers (biological tests)
Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes	120 months	Analysis of discordant cases regarding genomic/tumor size prognostic factors

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France