Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME) (SALOME)
Primary Purpose
Uveal Melanoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
About this trial
This is an interventional health services research trial for Uveal Melanoma focused on measuring uveal melanoma
Eligibility Criteria
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.
Sites / Locations
- Institut CurieRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with uveal melanoma
Arm Description
Outcomes
Primary Outcome Measures
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
Biological studies (lymphocyte phenotype and circulating tumor DNA)
lymphocyte phenotype analysis with biological tests
Biological studies (lymphocyte phenotype and circulating tumor DNA)
circulating tumor DNA analysis with biological tests
Secondary Outcome Measures
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
collection of biological samples (circulating tumor DNA analyses)
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
collection of biological samples (immune-monitoring analyses) with biological tests
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
collection of biological samples (sequencing analyses) with biological tests
Comparison of clinical and imaging data between the patients with and without identified biomarkers
Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)
Comparison of clinical and imaging data between the patients with and without identified biomarkers
Comparison of clinical data (medical patients records) between the patients with and without identified biomarkers (biological tests)
Univariate analysis of the prognostic value of identified biomarkers
prognostic value of identified biomarkers analysis with biological tests
Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data
Multivariate analysis of the prognostic value of identifies biomarkers (biological tests) adjusted for clinical (medical patients records) and imaging data (MRI)
Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes
Analysis of discordant cases regarding genomic/tumor size prognostic factors
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04424719
Brief Title
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Acronym
SALOME
Official Title
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
July 8, 2035 (Anticipated)
Study Completion Date
July 8, 2036 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma
Keywords
uveal melanoma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with uveal melanoma
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood test
Other Intervention Name(s)
MRI in routine
Intervention 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).
Primary Outcome Measure Information:
Title
Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers
Description
metastatic events and treatments reports correlation with their ocrresponding biomarquers
Time Frame
120 months
Title
Biological studies (lymphocyte phenotype and circulating tumor DNA)
Description
lymphocyte phenotype analysis with biological tests
Time Frame
120 months
Title
Biological studies (lymphocyte phenotype and circulating tumor DNA)
Description
circulating tumor DNA analysis with biological tests
Time Frame
120 months
Secondary Outcome Measure Information:
Title
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
Description
collection of biological samples (circulating tumor DNA analyses)
Time Frame
120 months
Title
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
Description
collection of biological samples (immune-monitoring analyses) with biological tests
Time Frame
120 months
Title
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
Description
collection of biological samples (sequencing analyses) with biological tests
Time Frame
120 months
Title
Comparison of clinical and imaging data between the patients with and without identified biomarkers
Description
Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)
Time Frame
120 months
Title
Comparison of clinical and imaging data between the patients with and without identified biomarkers
Description
Comparison of clinical data (medical patients records) between the patients with and without identified biomarkers (biological tests)
Time Frame
120 months
Title
Univariate analysis of the prognostic value of identified biomarkers
Description
prognostic value of identified biomarkers analysis with biological tests
Time Frame
120 months
Title
Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data
Description
Multivariate analysis of the prognostic value of identifies biomarkers (biological tests) adjusted for clinical (medical patients records) and imaging data (MRI)
Time Frame
120 months
Title
Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes
Description
Analysis of discordant cases regarding genomic/tumor size prognostic factors
Time Frame
120 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Piperno-Neumann, MD
Phone
01 44 32 46 72
Email
sophie.piperno-neumann@curie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Emmanuelle Legrier, PhD
Phone
01 56 24 56 49
Email
drci.promotion@curie.fr
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Emmanuelle Legrier, PhD
Phone
0156245649
Email
drci.promotion@curie.fr
First Name & Middle Initial & Last Name & Degree
Sophie PIPERNO-NEUMANN, MD
12. IPD Sharing Statement
Learn more about this trial
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
We'll reach out to this number within 24 hrs