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

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ClinicalTrials.gov Identifier: NCT04424719
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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.

Condition or disease Intervention/treatment Phase
Uveal Melanoma Other: Blood test Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
Actual Study Start Date : July 3, 2020
Estimated Primary Completion Date : June 15, 2025
Estimated Study Completion Date : June 15, 2035


Arm Intervention/treatment
Patients with uveal melanoma Other: Blood test

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).
Other Name: MRI in routine




Primary Outcome Measures :
  1. Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers [ Time Frame: 120 months ]
    metastatic events and treatments reports correlation with their ocrresponding biomarquers

  2. Biological studies (lymphocyte phenotype and circulating tumor DNA) [ Time Frame: 120 months ]
    lymphocyte phenotype analysis with biological tests

  3. Biological studies (lymphocyte phenotype and circulating tumor DNA) [ Time Frame: 120 months ]
    circulating tumor DNA analysis with biological tests


Secondary Outcome Measures :
  1. Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [ Time Frame: 120 months ]
    collection of biological samples (circulating tumor DNA analyses)

  2. Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [ Time Frame: 120 months ]
    collection of biological samples (immune-monitoring analyses) with biological tests

  3. Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [ Time Frame: 120 months ]
    collection of biological samples (sequencing analyses) with biological tests

  4. Comparison of clinical and imaging data between the patients with and without identified biomarkers [ Time Frame: 120 months ]
    Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)

  5. Comparison of clinical and imaging data between the patients with and without identified biomarkers [ Time Frame: 120 months ]
    Comparison of clinical data (medical patients records) between the patients with and without identified biomarkers (biological tests)

  6. Univariate analysis of the prognostic value of identified biomarkers [ Time Frame: 120 months ]
    prognostic value of identified biomarkers analysis with biological tests

  7. Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data [ 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)

  8. Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes [ Time Frame: 120 months ]
    Analysis of discordant cases regarding genomic/tumor size prognostic factors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424719


Contacts
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Contact: Sophie Piperno-Neumann, MD 01 44 32 46 72 sophie.piperno-neumann@curie.fr
Contact: Marie-Emmanuelle Legrier, PhD 01 56 24 56 49 drci.promotion@curie.fr

Locations
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France
Institut Curie Recruiting
Paris, France, 75005
Contact: Marie-Emmanuelle Legrier, PhD    0156245649    drci.promotion@curie.fr   
Principal Investigator: Sophie PIPERNO-NEUMANN, MD         
Sponsors and Collaborators
Institut Curie
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04424719    
Other Study ID Numbers: IC2019-13 SALOME
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Curie:
uveal melanoma
Additional relevant MeSH terms:
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Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases