Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Institut Curie

Status: Completed

Conditions: Choroidal Melanoma, Diffuse

Treatments: Biological: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT01334008

IC 2010-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Blood sampling

Other group

Treatment:

Biological: Blood sampling