Overview

This trial is active, not recruiting.

Condition choroidal melanoma
Treatment blood sampling
Sponsor Institut Curie
Start date April 2013
End date April 2019
Trial size 800 participants
Trial identifier NCT02875652, IC 2012-08

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
blood sampling
3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.

Primary Outcomes

Measure
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.

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma
Principal investigator Laurence Desjardins, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Institut Curie.