<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04424719</url>
  </required_header>
  <id_info>
    <org_study_id>IC2019-13 SALOME</org_study_id>
    <nct_id>NCT04424719</nct_id>
  </id_info>
  <brief_title>Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)</brief_title>
  <acronym>SALOME</acronym>
  <official_title>Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Curie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Curie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who&#xD;
      benefit from a follow-up tailored to their personalized risk of relapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High risk patients are referred for the medical oncology consultation to organize oncological&#xD;
      surveillance after general staging of the disease. Signature of the informed consent of&#xD;
      SALOME study, inclusion in the study and risk-adjusted surveillance schedule :&#xD;
&#xD;
      (i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).&#xD;
&#xD;
      (ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months&#xD;
      according to the schedule below. Plasma and mononucleated cells will be isolated and&#xD;
      preserved for bio-markers research.&#xD;
&#xD;
        -  M0 : during the first medical oncology visit.&#xD;
&#xD;
        -  At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years&#xD;
           maximum (M120).&#xD;
&#xD;
        -  At the diagnosis of metastasis.&#xD;
&#xD;
        -  At each significant event during the metastatic disease (surgery, treatment response or&#xD;
           progression).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">July 8, 2036</completion_date>
  <primary_completion_date type="Anticipated">July 8, 2035</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers</measure>
    <time_frame>120 months</time_frame>
    <description>metastatic events and treatments reports correlation with their ocrresponding biomarquers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biological studies (lymphocyte phenotype and circulating tumor DNA)</measure>
    <time_frame>120 months</time_frame>
    <description>lymphocyte phenotype analysis with biological tests</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biological studies (lymphocyte phenotype and circulating tumor DNA)</measure>
    <time_frame>120 months</time_frame>
    <description>circulating tumor DNA analysis with biological tests</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)</measure>
    <time_frame>120 months</time_frame>
    <description>collection of biological samples (circulating tumor DNA analyses)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)</measure>
    <time_frame>120 months</time_frame>
    <description>collection of biological samples (immune-monitoring analyses) with biological tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)</measure>
    <time_frame>120 months</time_frame>
    <description>collection of biological samples (sequencing analyses) with biological tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of clinical and imaging data between the patients with and without identified biomarkers</measure>
    <time_frame>120 months</time_frame>
    <description>Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of clinical and imaging data between the patients with and without identified biomarkers</measure>
    <time_frame>120 months</time_frame>
    <description>Comparison of clinical data (medical patients records) between the patients with and without identified biomarkers (biological tests)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Univariate analysis of the prognostic value of identified biomarkers</measure>
    <time_frame>120 months</time_frame>
    <description>prognostic value of identified biomarkers analysis with biological tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data</measure>
    <time_frame>120 months</time_frame>
    <description>Multivariate analysis of the prognostic value of identifies biomarkers (biological tests) adjusted for clinical (medical patients records) and imaging data (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes</measure>
    <time_frame>120 months</time_frame>
    <description>Analysis of discordant cases regarding genomic/tumor size prognostic factors</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Uveal Melanoma</condition>
  <arm_group>
    <arm_group_label>Patients with uveal melanoma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <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 :&#xD;
(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).&#xD;
(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.&#xD;
M0 : during the first medical oncology visit.&#xD;
At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120).&#xD;
At the diagnosis of metastasis.&#xD;
At each significant event during the metastatic disease (surgery, treatment response or progression).</description>
    <arm_group_label>Patients with uveal melanoma</arm_group_label>
    <other_name>MRI in routine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient aged of 18 years or more.&#xD;
&#xD;
          2. Patient with uveal melanoma with high metastatic relapse risk defined as :&#xD;
&#xD;
               -  T2b/c/d ou ≥ T3,&#xD;
&#xD;
               -  or chromosom 3 or chromosom 8 abnormality by CGH array.&#xD;
&#xD;
          3. Completion of treatment of the primary tumor ≤ 2 months.&#xD;
&#xD;
          4. Patient able to comply with the schedule of visits and blood samples of the study.&#xD;
&#xD;
          5. Signed informed consent form or legal representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient without french social insurance.&#xD;
&#xD;
          2. Any social, medical or psychological condition making the research process impossible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sophie Piperno-Neumann, MD</last_name>
    <phone>01 44 32 46 72</phone>
    <email>sophie.piperno-neumann@curie.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie-Emmanuelle Legrier, PhD</last_name>
    <phone>01 56 24 56 49</phone>
    <email>drci.promotion@curie.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie-Emmanuelle Legrier, PhD</last_name>
      <phone>0156245649</phone>
      <email>drci.promotion@curie.fr</email>
    </contact>
    <investigator>
      <last_name>Sophie PIPERNO-NEUMANN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>uveal melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Uveal Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04424719
org study id: IC2019-13 SALOME
nct id: NCT04424719
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers
time frame: 120 months
description: metastatic events and treatments reports correlation with their ocrresponding biomarquers
measure: Biological studies (lymphocyte phenotype and circulating tumor DNA)
time frame: 120 months
description: lymphocyte phenotype analysis with biological tests
measure: Biological studies (lymphocyte phenotype and circulating tumor DNA)
time frame: 120 months
description: circulating tumor DNA analysis with biological tests
measure: Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
time frame: 120 months
description: collection of biological samples (circulating tumor DNA analyses)
measure: Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
time frame: 120 months
description: collection of biological samples (immune-monitoring analyses) with biological tests
measure: Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)
time frame: 120 months
description: collection of biological samples (sequencing analyses) with biological tests
measure: Comparison of clinical and imaging data between the patients with and without identified biomarkers
time frame: 120 months
description: Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)
measure: Comparison of clinical and imaging data between the patients with and without identified biomarkers
time frame: 120 months
description: Comparison of clinical data (medical patients records) between the patients with and without identified biomarkers (biological tests)
measure: Univariate analysis of the prognostic value of identified biomarkers
time frame: 120 months
description: prognostic value of identified biomarkers analysis with biological tests
measure: Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data
time frame: 120 months
description: Multivariate analysis of the prognostic value of identifies biomarkers (biological tests) adjusted for clinical (medical patients records) and imaging data (MRI)
measure: Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes
time frame: 120 months
description: Analysis of discordant cases regarding genomic/tumor size prognostic factors
arm group label: Patients with uveal melanoma
arm group type: Other
intervention type: Other
intervention name: Blood test
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).
arm group label: Patients with uveal melanoma
other name: MRI in routine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophie Piperno-Neumann, MD
phone: 01 44 32 46 72
email: sophie.piperno-neumann@curie.fr
last name: Marie-Emmanuelle Legrier, PhD
phone: 01 56 24 56 49
email: drci.promotion@curie.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Uveal Neoplasms