Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)

Choroidal Melanoma Clinical Trial

— ctDNA MU  

Official title:

Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875652
• Other study ID #: IC 2012-08
• Status: Completed
• Phase: N/A
• Start date: March 21, 2013
• Est. completion date: April 2, 2019

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: April 2, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Melanoma
• Melanoma

Intervention

Biological:
• Blood sampling
3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

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