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

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

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

Study Overview

• Status: Completed
• Conditions: Uveal Melanoma
• Intervention / Treatment: Biological: Blood sampling

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biological/Vaccine	Biological: Blood sampling; 7,5 ml of patient peripherical blood will be collected at each blood sample.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection	Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.	Up to one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stability of the circulating tumor DNA on 2 pre-surgery samples	Comparison the circulating tumor DNA rate before/after surgery	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.	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.	two years
Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis	Search of GNA 11 or GNAQ mutation by Next Generation Sequencing techniques	Up to one month
Comparative study of the mutation profile of the ocular tumor if available, resected 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
Detection of genetic factors for uveal melanoma	Search of genetic factors for uveal melanoma to be used as predictive evidence of the clinical response for possible future treatment	Up to one month
Study of overall survival after HMUM resection		5 years

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Pascale Mariani, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): February 25, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimated): July 29, 2016

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Circulating tumor DNA
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Uveal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Melanoma; Uveal Neoplasms
• Other Study ID Numbers: IC 2014-06 ctDNA R0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: SAP