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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 February 2024 |
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Main ID: |
NCT01334008 |
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Date of registration:
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31/03/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma
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Scientific title:
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Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01334008 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Sophie PIPERNO-NEUMANN, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Curie |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Choroidal Melanoma, Diffuse
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Intervention(s)
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Biological: Blood sampling
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Primary Outcome(s)
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Assessment and development of circulating tumor DNA detection techniques
[Time Frame: 2 years]
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Secondary Outcome(s)
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Detection technique comparison (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(next sequencing generation)) in terms of feasibility, robustness, sensitivity and cost.
[Time Frame: 2 years]
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Secondary ID(s)
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IC 2010-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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