Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)

Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02875652

Acronym

ctDNA MU

Enrollment

800

Registered

2016-08-23

Start date

2013-03-21

Completion date

2019-04-02

Last updated

2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal Melanoma

Keywords

circulation tumor DNA, choroidal melanoma

Brief summary

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

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.

Interventions

BIOLOGICALBlood sampling

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026