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

NCT04424719 | Recruiting

• 1 other identifier: IC2019-13
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveal Melanoma

Keywords

uveal melanoma

Outcome Measures

Primary Outcomes (3)

• 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 study (lymphocytes)

  lymphocyte phenotype analysis with biological tests

  120 months

• Biological study (ctDNA)

  circulating tumor DNA analysis with biological tests

  120 months

Secondary Outcomes (8)

• Biological samples prospective collection (ctDNA)

  120 months

• Biological samples prospective collection (immune-monitoring analyses)

  120 months

• Biological samples prospective collection (sequencing analyses)

  120 months

• Comparison of clinical and imaging data (MRI)

  120 months

• Comparison of clinical and imaging data (clinical data)

  120 months

Study Arms (1)

Patients with uveal melanoma

OTHER

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.

Other: Blood test

Interventions

Blood test OTHER

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).

Also known as: MRI in routine

Patients with uveal melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged of 18 years or more.
• 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.
• Completion of treatment of the primary tumor ≤ 2 months.
• Patient able to comply with the schedule of visits and blood samples of the study.
• Signed informed consent form or legal representative.

You may not qualify if:

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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Hematologic Tests; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Sophie Piperno-Neumann, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Piperno-Neumann, MD

CONTACT

01 44 32 46 72; sophie.piperno-neumann@curie.fr

Marie-Emmanuelle Legrier, PhD

CONTACT

01 56 24 56 49; drci.promotion@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 11, 2020
• Study Start: July 8, 2020
• Primary Completion (Estimated): July 7, 2037
• Study Completion (Estimated): July 7, 2037
• Last Updated: September 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• 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).

Locations

FR (1)