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

Uveal Melanoma Clinical Trial

— SALOME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424719
• Other study ID #: IC2019-13 SALOME
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: July 26, 2035

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: Sophie Piperno-Neumann, MD
• Phone: 01 44 32 46 72
• Email: sophie.piperno-neumann[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: July 26, 2035
• Est. primary completion date: July 26, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

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).

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	120 months
Primary	Biological studies (lymphocyte phenotype and circulating tumor DNA)	lymphocyte phenotype analysis with biological tests	120 months
Primary	Biological studies (lymphocyte phenotype and circulating tumor DNA)	circulating tumor DNA analysis with biological tests	120 months
Secondary	Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)	collection of biological samples (circulating tumor DNA analyses)	120 months
Secondary	Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)	collection of biological samples (immune-monitoring analyses) with biological tests	120 months
Secondary	Prospective collection of biological samples (circulating tumor DNA, immune-monitoring, sequencing analyses)	collection of biological samples (sequencing analyses) with biological tests	120 months
Secondary	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)	120 months
Secondary	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)	120 months
Secondary	Univariate analysis of the prognostic value of identified biomarkers	prognostic value of identified biomarkers analysis with biological tests	120 months
Secondary	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)	120 months
Secondary	Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes	Analysis of discordant cases regarding genomic/tumor size prognostic factors	120 months