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


N/A
18 Years
N/A
Open (Enrolling)
Both
Choroidal Melanoma, Diffuse

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Assessment and development of circulating tumor DNA detection techniques

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Sophie PIPERNO-NEUMANN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Curie

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IC 2010-02

NCT ID:

NCT01334008

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Choroidal Melanoma, Diffuse
  • Circulating tumor DNA
  • Choroidal Melanoma
  • Melanoma

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