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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2035
  • participants needed
    700
  • sponsor
    Institut Curie
Updated on 27 January 2021

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.

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).

Details
Condition Uveal Melanoma
Treatment Blood test
Clinical Study IdentifierNCT04424719
SponsorInstitut Curie
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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