Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Institut Curie.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut Curie
ClinicalTrials.gov Identifier:
NCT01334008
First received: March 31, 2011
Last updated: May 9, 2011
Last verified: March 2011
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2011
Intervention Details:
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334008

Locations
France
Institut Curie Recruiting
Paris, France, 75005
Contact: Sylvie MARAL, UGEC leader    +33156245632    melanie.lebegue@curie.net   
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: Sophie PIPERNO-NEUMANN, MD Institut Curie
  More Information

No publications provided

Responsible Party: Mme Sylvie MARAL, INSTITUT CURIE
ClinicalTrials.gov Identifier: NCT01334008     History of Changes
Other Study ID Numbers: IC 2010-02
Study First Received: March 31, 2011
Last Updated: May 9, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 21, 2014