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

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.

Study Overview

• Status: Recruiting
• Conditions: Uveal Melanoma
• Intervention / Treatment: Other: Blood test

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 Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie Piperno-Neumann, MD; Phone Number: 01 44 32 46 72; Email: sophie.piperno-neumann@curie.fr
• Study Contact Backup: Name: Marie-Emmanuelle Legrier, PhD; Phone Number: 01 56 24 56 49; Email: drci.promotion@curie.fr

Study Locations

• France
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Principal Investigator: Sophie PIPERNO-NEUMANN, MD
    • Contact: Marie-Emmanuelle Legrier, PhD; Phone Number: 0156245649; Email: drci.promotion@curie.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients with uveal melanoma

Other: 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 Names: MRI in routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers	metastatic events and treatments reports correlation with their ocrresponding biomarquers	120 months
Biological studies (lymphocyte phenotype and circulating tumor DNA)	lymphocyte phenotype analysis with biological tests	120 months
Biological studies (lymphocyte phenotype and circulating tumor DNA)	circulating tumor DNA analysis with biological tests	120 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Estimated): July 26, 2035
• Study Completion (Estimated): July 26, 2035

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: uveal melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Uveal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Melanoma; Uveal Neoplasms
• Other Study ID Numbers: IC2019-13 SALOME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No