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

• ClinicalTrials.gov Identifier: NCT04424719
• Recruitment Status: Recruiting
• First Posted: June 11, 2020
• Last Update Posted: January 30, 2024
• Sponsor: Institut Curie
• Information provided by (Responsible Party): Institut Curie

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Uveal Melanoma	Other: Blood test	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 700 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
• Actual Study Start Date: July 8, 2020
• Estimated Primary Completion Date: July 26, 2035
• Estimated Study Completion Date: July 26, 2035

Arms and Interventions

Arm

Intervention/treatment

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 Name: MRI in routine

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [ Time Frame: 120 months ]
   collection of biological samples (circulating tumor DNA analyses)
2. Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [ Time Frame: 120 months ]
   collection of biological samples (immune-monitoring analyses) with biological tests
3. Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [ Time Frame: 120 months ]
   collection of biological samples (sequencing analyses) with biological tests
4. Comparison of clinical and imaging data between the patients with and without identified biomarkers [ Time Frame: 120 months ]
   Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)
5. Comparison of clinical and imaging data between the patients with and without identified biomarkers [ Time Frame: 120 months ]
   Comparison of clinical data (medical patients records) between the patients with and without identified biomarkers (biological tests)
6. Univariate analysis of the prognostic value of identified biomarkers [ Time Frame: 120 months ]
   prognostic value of identified biomarkers analysis with biological tests
7. Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data [ Time Frame: 120 months ]
   Multivariate analysis of the prognostic value of identifies biomarkers (biological tests) adjusted for clinical (medical patients records) and imaging data (MRI)
8. Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes [ Time Frame: 120 months ]
   Analysis of discordant cases regarding genomic/tumor size prognostic factors

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Sophie Piperno-Neumann, MD; 01 44 32 46 72; sophie.piperno-neumann@curie.fr

Contact: Marie-Emmanuelle Legrier, PhD; 01 56 24 56 49; drci.promotion@curie.fr

Locations

France

Institut Curie; Recruiting

Paris, France, 75005

Contact: Marie-Emmanuelle Legrier, PhD 0156245649 drci.promotion@curie.fr

Principal Investigator: Sophie PIPERNO-NEUMANN, MD

Sponsors and Collaborators

Institut Curie

More Information

• Responsible Party: Institut Curie
• ClinicalTrials.gov Identifier: NCT04424719
• Other Study ID Numbers: IC2019-13 SALOME
• First Posted: June 11, 2020
• Last Update Posted: January 30, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (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).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Curie:

uveal melanoma

Additional relevant MeSH terms:

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