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

Not Applicable

Completed

• Conditions: Uveal Melanoma
• Interventions: Biological: Blood sampling

• Registration Number: 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biological/Vaccine	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection	Up to one month	Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.

Secondary Outcome Measures

Name	Time	Method
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	Timepoints : T0 and T1 : before surgery T2 : 2 days after surgery T3 : 8 days after surgery T4 to T9 : every 4 months up to two years.
Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis	Up to one month	Search of GNA 11 or GNAQ mutation by Next Generation Sequencing techniques
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	Comparison the circulating tumor DNA rate before/after surgery
Detection of genetic factors for uveal melanoma	Up to one month	Search of genetic factors for uveal melanoma to be used as predictive evidence of the clinical response for possible future treatment
Study of overall survival after HMUM resection	5 years

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France