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Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01334008
First Posted: April 12, 2011
Last Update Posted: July 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Curie
  Purpose
Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

Condition Intervention
Choroidal Melanoma, Diffuse Biological: Blood sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma

Resource links provided by NLM:


Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • Assessment and development of circulating tumor DNA detection techniques [ Time Frame: 2 years ]
    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. [ Time Frame: 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.


Enrollment: 40
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Blood sampling Biological: Blood sampling
30ml of patient peripherical blood will be collected

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334008


Locations
France
Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: Sophie PIPERNO-NEUMANN, MD Institut Curie
  More Information

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01334008     History of Changes
Other Study ID Numbers: IC 2010-02
First Submitted: March 31, 2011
First Posted: April 12, 2011
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Institut Curie:
Circulating tumor DNA
Choroidal Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas