Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU) (ctDNA MU)

January 29, 2024 updated by: Institut Curie

Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma

Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, open-labelled, monocentric trial. The aim is to observe, in patient with choroidal melanoma (any stage of the disease), the prevalence of the circulating tumor DNA at the diagnostic and its evolution during 3 years.

The patient will have a blood sample at the following times :

  • T0: before treatment of the primary tumor.
  • T1: 1 months after the end of the local treatment.
  • T2: at 7 months.
  • Tn: every 6 months up to 3 years.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75005
        • Institut Curie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years old or more.
  • Patient with a recent choroidal melanoma before the start of the specific treatment.
  • Patient able to stand a blood collection.
  • Work-up for extension (CT).
  • Patient explanation given and consent information signed or by legal representative

Exclusion Criteria:

  • Patient without social protection / insurance.
  • Person deprived of liberty or under guardianship.
  • Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assesment of the change of the circulating tumor DNA from baseline at 3 years
Time Frame: T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.
T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA.
Time Frame: 3 years
3 years
Comparison of the circulating tumor DNA rate to hepatic imaging if available.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: Laurence Desjardins, MD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2013

Primary Completion (Actual)

April 2, 2019

Study Completion (Actual)

April 2, 2019

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 23, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2012-08

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

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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