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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04424719
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Curie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Uveal Melanoma

Additional Details

- 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).

Arms & Interventions

Arms

Other: Patients with uveal melanoma

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 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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Institut Curie, Paris, France

Status

Recruiting

Address

Institut Curie

Paris, , 75005

Site Contact

Marie-Emmanuelle Legrier, PhD

[email protected]

0156245649

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