Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Choroidal Melanoma, Diffuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334008
• Other study ID #: IC 2010-02
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Choroidal Melanoma, Diffuse
• Melanoma

Intervention

Biological:
• Blood sampling
30ml of patient peripherical blood will be collected

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years