Brief Title
Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)
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 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.
Study Type
Interventional
Primary Outcome
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
Secondary Outcome
stability of the circulating tumor DNA on 2 pre-surgery samples
Condition
Uveal Melanoma
Intervention
Blood sampling
Study Arms / Comparison Groups
Biological/Vaccine
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
60
Start Date
September 2014
Completion Date
February 25, 2020
Primary Completion Date
February 25, 2020
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pascale Mariani, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02849145
Organization ID
IC 2014-06 ctDNA R0
Responsible Party
Sponsor
Study Sponsor
Institut Curie
Study Sponsor
Pascale Mariani, MD, Principal Investigator, Institut Curie
Verification Date
August 2020