Clinical trial NCT02849145: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveal Melanoma
Keywords: Circulating tumor DNA
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
timeFrame: Up to one month
Secondary outcomes:
measure: stability of the circulating tumor DNA on 2 pre-surgery samples
timeFrame: Up to one month
measure: 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.
timeFrame: two years
measure: Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis
timeFrame: Up to one month
measure: Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis.
timeFrame: Up to one month
measure: Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis)
timeFrame: Up to one month
measure: Detection of genetic factors for uveal melanoma
timeFrame: Up to one month
measure: Study of overall survival after HMUM resection
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Pascale Mariani, MD
role: PRINCIPAL_INVESTIGATOR
References: