NCT02849145

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

5.5 years

First QC Date

July 13, 2016

Last Update Submit

September 15, 2025

Conditions

Uveal Melanoma

Keywords

Circulating tumor DNA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • stability of the circulating tumor DNA on 2 pre-surgery samples

    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

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Biological/Vaccine

EXPERIMENTAL
Biological: Blood sampling

Interventions

Blood samplingBIOLOGICAL

7,5 ml of patient peripherical blood will be collected at each blood sample.

Biological/Vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

Related Publications (1)

  • Mariani P, Bidard FC, Rampanou A, Houy A, Servois V, Ramtohul T, Pierron G, Chevrier M, Renouf B, Lantz O, Gardrat S, Vincent-Salomon A, Roman-Roman S, Rodrigues M, Piperno-Neumann S, Cassoux N, Stern MH, Renault S. Circulating Tumor DNA as a Prognostic Factor in Patients With Resectable Hepatic Metastases of Uveal Melanoma. Ann Surg. 2023 Oct 1;278(4):e827-e834. doi: 10.1097/SLA.0000000000005822. Epub 2023 Feb 27.

    PMID: 36847256RESULT

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pascale Mariani, MD

    Institut Curie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 29, 2016

Study Start

September 1, 2014

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Shared Documents
SAP
Time Frame
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
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).

Locations

FR(1)