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Completed

NCT Number: NCT02875652

Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)

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

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Key information

Conditions

Choroidal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Melanoma Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie

Paris, 75005, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma

Acronym: ctDNA MU

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2016
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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