Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)
This trial is active, not recruiting.
|Start date||April 2013|
|End date||April 2019|
|Trial size||800 participants|
|Trial identifier||NCT02875652, IC 2012-08|
Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma
|Intervention model||single group assignment|
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.
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
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
|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.|
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