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

Institut Curie60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Uveal Melanoma

Interventions

Blood samplingBIOLOGICAL

7,5 ml of patient peripherical blood will be collected at each blood sample.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 years old or more 2. Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0). 3. 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)). 4. Patient able to stand a blood collection. 5. Patient explanation given and consent information signed or by legal representative. Exclusion Criteria: 6. Patient without social protection / insurance.. 7. Patient with hepatic metastasis unresectable by surgery 8. Patient with extra-hepatic metastasis. 9. Person deprived of liberty or under guardianship 10. Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.

Locations (1)

Institut Curie

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: Up to one month

Secondary Outcomes

stability of the circulating tumor DNA on 2 pre-surgery samples

Comparison the circulating tumor DNA rate before/after surgery

Time frame: 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.

Time frame: 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

Time frame: Up to one month

Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis.

Time frame: Up to one month

Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis)

Time frame: 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

Data from ClinicalTrials.gov

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