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

Institut Curie

Status

Completed

Conditions

Uveal Melanoma

Treatments

Biological: Blood sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT02849145

IC 2014-06

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.