Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU) (ctDNA MU)
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|ClinicalTrials.gov Identifier: NCT02875652|
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Choroidal Melanoma||Biological: Blood sampling||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Experimental: Blood sampling||
Biological: Blood sampling
3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875652
|Paris, France, 75005|
|Principal Investigator:||Laurence Desjardins, MD||Institut Curie|