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Completed

NCT Number: NCT01334008

Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

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Key information

Conditions

Choroidal Melanoma, Diffuse 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

Technique development: In first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without GNAQ mutation.

Validation: The tumor DNA detection rate will be estimated from metastatic uveal patient's blood. The investigators will study 40 patients to obtain at least 15 patients bearing a GNAQ mutation in the primitive tumor or in metastasis. With those 15 patients, the investigators will determinate the most sensitive technique and the best cost/efficiency ratio.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > or = 18 years.
  • Patient with a metastatic choroidal melanoma.
  • Patient with tumor or metastasis available for GNAQ (Guanine nucleotide blinding protein) status characterization.
  • Patient able to stand a blood collection.
  • Signed written informed consent approved by competent authority and ethic committee.

Exclusion criteria

  • Patient without social protection/insurance.
  • Current pregnancy and lactation.
  • All social, medical, psychological, situations making the study impossible.
  • Person deprived of liberty.

Treatment and study plan

Blood sampling

Biological

30ml of patient peripherical blood will be collected

Primary outcomes

  1. Assessment and development of circulating tumor DNA detection techniques

    Time frame: 2 years

    Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.

Secondary outcomes

  1. Detection technique comparison (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(next sequencing generation)) in terms of feasibility, robustness, sensitivity and cost.

    Time frame: 2 years

    The methods of detection which will be used such as the BEAMing, the PAP (Pyrophosphorolysis-activated polymerization) and NGS (next sequencing generation)is techniques of a big specificity capable of detecting a mutant copy among 1.104 wild copies for the BEAMing, 2.109 for the PAP and 1.105 for the NGS. The sensibility of these techniques is limited by the quantity of genomic DNA which we can extract from the sample of blood.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2011
Registry last updated
Nov 24, 2025

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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