Clinical trial NCT04424719: Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Official title: Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uveal Melanoma
Keywords: uveal melanoma
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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).

Eligibility 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.

Primary outcomes:
measure: Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers
timeFrame: 120 months
measure: Biological studies (lymphocyte phenotype and circulating tumor DNA)
timeFrame: 120 months
measure: Biological studies (lymphocyte phenotype and circulating tumor DNA)
timeFrame: 120 months
Secondary outcomes:
measure: Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
timeFrame: 120 months
measure: Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
timeFrame: 120 months
measure: Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
timeFrame: 120 months
measure: Comparison of clinical and imaging data between the patients with and without identified biomarkers
timeFrame: 120 months
measure: Comparison of clinical and imaging data between the patients with and without identified biomarkers
timeFrame: 120 months
measure: Univariate analysis of the prognostic value of identified biomarkers
timeFrame: 120 months
measure: Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data
timeFrame: 120 months
measure: Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes
timeFrame: 120 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
References: