Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)
Overview
- Phase
- Not Applicable
- Intervention
- Blood sampling
- Conditions
- Uveal Melanoma
- Sponsor
- Institut Curie
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
Biological/Vaccine
Intervention: Blood sampling
Outcomes
Primary Outcomes
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
Time Frame: Up to one month
Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.
Secondary Outcomes
- Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis.(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.(two years)
- Detection of GNA11 or GNAQ mutation on one of the 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)
- stability of the circulating tumor DNA on 2 pre-surgery samples(Up to one month)
- Detection of genetic factors for uveal melanoma(Up to one month)
- Study of overall survival after HMUM resection(5 years)