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

ConditionUveal Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Curie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged of 18 years or more.

T2b/c/d ou ≥ T3,

or chromosom 3 or chromosom 8 abnormality by CGH array.

Completion of treatment of the primary tumor ≤ 2 months.

Disqualifiers

Patient without french social insurance.

Any social, medical or psychological condition making the research process impossible.

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood test

    Other intervention

    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).

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: Patients with uveal melanomaOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
120 months
2

Biological study (lymphocytes)

lymphocyte phenotype analysis with biological tests

Time frame
120 months
3

Biological study (ctDNA)

circulating tumor DNA analysis with biological tests

Time frame
120 months

Secondary outcomes

1

Biological samples prospective collection (ctDNA)

collection of biological samples (circulating tumor DNA analyses)

Time frame
120 months
2

Biological samples prospective collection (immune-monitoring analyses)

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

Time frame
120 months
3

Biological samples prospective collection (sequencing analyses)

collection of biological samples (sequencing analyses) with biological tests

Time frame
120 months
4

Comparison of clinical and imaging data (MRI)

Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)

Time frame
120 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Curie

Lead sponsor

Source ClinicalTrials.gov
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