Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Not Applicable

Completed

• Conditions: Choroidal Melanoma, Diffuse
• Interventions: Biological: Blood sampling

• Registration Number: NCT01334008
• Lead Sponsor: Institut Curie

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-03-31
• Study Start: 2011-04
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Primary Completion: 2012-02
• Study Completion: 2012-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sampling	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
Assessment and development of circulating tumor DNA detection techniques	2 years	Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France