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

Sponsor

Institut Curie (Other)

Overall Status

Recruiting

CT.gov ID

NCT04424719

Collaborator

(none)

700

Enrollment

Location

Arm

179.4

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma	Other: Blood test	N/A

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).

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 3, 2020

Anticipated Primary Completion Date :

Jun 15, 2025

Anticipated Study Completion Date :

Jun 15, 2035

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: MRI in routine

Arm

Intervention/Treatment

Other: 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 Names:

MRI in routine

Outcome Measures

Primary Outcome Measures

Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers [120 months]
metastatic events and treatments reports correlation with their ocrresponding biomarquers
Biological studies (lymphocyte phenotype and circulating tumor DNA) [120 months]
lymphocyte phenotype analysis with biological tests
Biological studies (lymphocyte phenotype and circulating tumor DNA) [120 months]
circulating tumor DNA analysis with biological tests

Secondary Outcome Measures

Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [120 months]
collection of biological samples (circulating tumor DNA analyses)
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [120 months]
collection of biological samples (immune-monitoring analyses) with biological tests
Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses) [120 months]
collection of biological samples (sequencing analyses) with biological tests
Comparison of clinical and imaging data between the patients with and without identified biomarkers [120 months]
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 [120 months]
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 [120 months]
prognostic value of identified biomarkers analysis with biological tests
Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data [120 months]
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 [120 months]
Analysis of discordant cases regarding genomic/tumor size prognostic factors

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Curie	Paris		France	75005

Sponsors and Collaborators

Institut Curie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Curie

ClinicalTrials.gov Identifier:

NCT04424719

Other Study ID Numbers:

IC2019-13 SALOME

First Posted:

Jun 11, 2020

Last Update Posted:

Jan 12, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Institut Curie

uveal melanoma

Additional relevant MeSH terms:

Melanoma

Uveal Neoplasms

Study Results

No Results Posted as of Jan 12, 2021