Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)

Study Overview
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Brief Summary
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Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up

Detailed Description
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The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to evaluate the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up. The patient will have a blood sample before and after the surgery and during the post-surgery follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.

Official Title
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Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)

Conditions
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Uveal Melanoma

Intervention / Treatment
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* Biological: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years old or more Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0). No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)). Patient able to stand a blood collection. Patient explanation given and consent information signed or by legal representative. Exclusion Criteria: Patient without social protection / insurance.. Patient with hepatic metastasis unresectable by surgery Patient with extra-hepatic metastasis. Person deprived of liberty or under guardianship Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological/Vaccine<br> | Biological: Blood sampling<br>* 7,5 ml of patient peripherical blood will be collected at each blood sample.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection | Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection. | Up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stability of the circulating tumor DNA on 2 pre-surgery samples | Comparison the circulating tumor DNA rate before/after surgery | Up to one month | 
| Study of the correlation between the variation rate of the circulating tumor DNA at different points (T0, T1, T2, T3, T4 and Tn) and the apparition time of metastasis on hepatic MRI during the study follow-up. | Timepoints : T0 and T1 : before surgery T2 : 2 days after surgery T3 : 8 days after surgery T4 to T9 : every 4 months up to two years. | two years | 
| Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis | Search of GNA 11 or GNAQ mutation by Next Generation Sequencing techniques | Up to one month | 
| Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis. |  | Up to one month | 
| Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis) |  | Up to one month | 
| Detection of genetic factors for uveal melanoma | Search of genetic factors for uveal melanoma to be used as predictive evidence of the clinical response for possible future treatment | Up to one month | 
| Study of overall survival after HMUM resection |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating tumor DNA