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Recruiting NCT04424719

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

No phase Interventional Uveal Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood test.
Who it may be relevant to
Registry conditions: Uveal Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • 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 mononucl

Primary outcome measures

  • Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers [Time frame: 120 months]
  • Biological study (lymphocytes) [Time frame: 120 months]
  • Biological study (ctDNA) [Time frame: 120 months]
Secondary outcome measures (8)
  • Biological samples prospective collection (ctDNA) [Time frame: 120 months]
  • Biological samples prospective collection (immune-monitoring analyses) [Time frame: 120 months]
  • Biological samples prospective collection (sequencing analyses) [Time frame: 120 months]
  • Comparison of clinical and imaging data (MRI) [Time frame: 120 months]
  • Comparison of clinical and imaging data (clinical data) [Time frame: 120 months]
  • Univariate analysis of the prognostic value of identified biomarkers [Time frame: 120 months]
  • Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data [Time frame: 120 months]
  • Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes [Time frame: 120 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • Institut Curie — Paris

Identifiers

NCT: NCT04424719 · IC2019-13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗