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CompletedNCT01334008Updated Nov 24, 2025

Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

An interventional study of Blood sampling in Choroidal Melanoma, Diffuse, sponsored by Institut Curie. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by Institut Curie · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Choroidal Melanoma, Diffuse

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Keywords

  • Circulating tumor DNA
  • Choroidal Melanoma
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In context

Uveal Melanoma

103 studies on the registry are indexed under Uveal Melanoma; 38 are open to participants now.

This study's enrollment of 40 is close to the median of 42 across 93 interventional studies indexed under Uveal Melanoma.

Browse Uveal Melanoma studies →

Lead sponsor

Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Other
    Blood sampling

    Biological: Blood sampling

Interventions

  • BiologicalBlood sampling

    30ml of patient peripherical blood will be collected

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What researchers measure

Primary outcomes

  1. Assessment and development of circulating tumor DNA detection techniques

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

    Time frame: 2 years

Secondary outcomes

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

    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.

    Time frame: 2 years

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Study locations

1 site
  • Institut Curie
    Paris, 75005, France
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References and documents

Publications

  • Bidard FC, Madic J, Mariani P, Piperno-Neumann S, Rampanou A, Servois V, Cassoux N, Desjardins L, Milder M, Vaucher I, Pierga JY, Lebofsky R, Stern MH, Lantz O. Detection rate and prognostic value of circulating tumor cells and circulating tumor DNA in metastatic uveal melanoma. Int J Cancer. 2014 Mar 1;134(5):1207-13. doi: 10.1002/ijc.28436. Epub 2013 Sep 3. PubMed 23934701 ↗

Individual participant data

Plan to share: Yes — Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01334008
Lead sponsor
Institut Curie
Responsible party
Sponsor
First posted
Apr 12, 2011
Start date
Apr 2011
Primary completion
Feb 2012
Completion
May 2012
Last update
Nov 24, 2025

Study contacts

Sophie PIPERNO-NEUMANN, MD
principal investigator · Institut Curie

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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