Institut Curie
Paris, 75005, France
Location status: Recruiting
Location contact
Marie-Emmanuelle Legrier, PhD
CONTACT
Sophie PIPERNO-NEUMANN, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04424719
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, 75005, France
Location status: Recruiting
Marie-Emmanuelle Legrier, PhD
CONTACT
Sophie PIPERNO-NEUMANN, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: MRI in routine
Time frame: 120 months
metastatic events and treatments reports correlation with their ocrresponding biomarquers
Time frame: 120 months
lymphocyte phenotype analysis with biological tests
Time frame: 120 months
circulating tumor DNA analysis with biological tests
Time frame: 120 months
collection of biological samples (circulating tumor DNA analyses)
Time frame: 120 months
collection of biological samples (immune-monitoring analyses) with biological tests
Time frame: 120 months
collection of biological samples (sequencing analyses) with biological tests
Time frame: 120 months
Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)
Time frame: 120 months
Comparison of clinical data between the patients with and without identified biomarkers (biological tests)
Time frame: 120 months
prognostic value of identified biomarkers analysis with biological tests
Time frame: 120 months
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
Analysis of discordant cases regarding genomic/tumor size prognostic factors
Contact information is provided by the study sponsor or research team.
Marie-Emmanuelle Legrier, PhD
CONTACT
Sophie Piperno-Neumann, MD
CONTACT
Institut Curie
Other
Acronym: SALOME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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