Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)

Not Applicable

Completed

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

• Registration Number: NCT02875652
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study Start: 2013-03-21
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-23
• Primary Completion: 2019-04-02
• Study Completion: 2019-04-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sampling	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France