Official Title
Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)
Brief Title
Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)
Protocol ID
NCT02849145
Lead Sponsor
Institut Curie
Brief Summary
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
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 Count
60 participants
Eligibility Criteria
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.
Filters
Uveal Melanoma
NA
COMPLETED
ADULT
OLDER_ADULT