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NCT Number: NCT04424719

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie

Paris, 75005, France

Location status: Recruiting

Location contact

Marie-Emmanuelle Legrier, PhD

CONTACT

[email protected]

0156245649

Sophie PIPERNO-NEUMANN, MD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: MRI in routine

Primary outcomes

  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 study (lymphocytes)

    Time frame: 120 months

    lymphocyte phenotype analysis with biological tests

  3. Biological study (ctDNA)

    Time frame: 120 months

    circulating tumor DNA analysis with biological tests

Secondary outcomes

  1. Biological samples prospective collection (ctDNA)

    Time frame: 120 months

    collection of biological samples (circulating tumor DNA analyses)

  2. Biological samples prospective collection (immune-monitoring analyses)

    Time frame: 120 months

    collection of biological samples (immune-monitoring analyses) with biological tests

  3. Biological samples prospective collection (sequencing analyses)

    Time frame: 120 months

    collection of biological samples (sequencing analyses) with biological tests

  4. Comparison of clinical and imaging data (MRI)

    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 (clinical data)

    Time frame: 120 months

    Comparison of clinical data 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Emmanuelle Legrier, PhD

CONTACT

[email protected]

01 56 24 56 49

Sophie Piperno-Neumann, MD

CONTACT

[email protected]

01 44 32 46 72

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: SALOME

Important dates

Study start
2020
Primary completion
2037
Study completion
2037
First posted
Jun 11, 2020
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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