Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU) (ctDNA MU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02875652
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : April 6, 2018
Information provided by (Responsible Party):
Institut Curie

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

Condition or disease Intervention/treatment Phase
Choroidal Melanoma Biological: Blood sampling Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Blood sampling Biological: Blood sampling
3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA. [ Time Frame: 3 years ]
  2. Comparison of the circulating tumor DNA rate to hepatic imaging if available. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02875652

Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Institut Curie
Principal Investigator: Laurence Desjardins, MD Institut Curie

Responsible Party: Institut Curie Identifier: NCT02875652     History of Changes
Other Study ID Numbers: IC 2012-08
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Institut Curie:
circulation tumor DNA
choroidal melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas