Back to resultsStudy of Circulating Tumoral DNA in Metastatic Choroidal Melanoma
Primary Purpose
Choroidal Melanoma, Diffuse
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Choroidal Melanoma, Diffuse focused on measuring Circulating tumor DNA, Choroidal Melanoma
Eligibility Criteria
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.
Sites / Locations
- Institut Curie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Blood sampling
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01334008
Brief Title
Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma
Official Title
Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Melanoma, Diffuse
Keywords
Circulating tumor DNA, Choroidal Melanoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood sampling
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
30ml of patient peripherical blood will be collected
Primary Outcome Measure Information:
Title
Assessment and development of circulating tumor DNA detection techniques
Description
Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Detection technique comparison (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(next sequencing generation)) in terms of feasibility, robustness, sensitivity and cost.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie PIPERNO-NEUMANN, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma
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