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Study of Circulating Tumoral DNA in Ovarian Cancer

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:
NCT01350908
First received: May 6, 2011
Last updated: May 9, 2011
Last verified: March 2011

May 6, 2011
May 9, 2011
April 2011
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01350908 on ClinicalTrials.gov Archive Site
Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to 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 the 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.
Same as current
Not Provided
Not Provided
 
Study of Circulating Tumoral DNA in Ovarian Cancer
Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer

Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Technique development:

In a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without TP53 mutation.

Validation:

The tumor DNA detection rate will be estimated from patient's blood with ovarian cancer.

The investigators will study 25 patients to obtain at least 15 patients bearing a TP53 mutation that could be characterized in the primitive tumor or metastasis. With those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Ovarian Cancer
Other: Blood sampling
30mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > or = 18 years.
  • Patient with invasive ovarian cancer stage II to IV from FIGO classification.
  • Patient treated by surgery.
  • Patient with tumor or metastasis available for TP53 status characterization
  • Patient able to stand a blood collection.
  • Signed written informed consent approved by AFSSAPS and CPP.

Exclusion Criteria:

  • Patient without social protection / insurance.
  • Borderline ovarian tumor.
  • Non carcinoma ovarian tumor
  • Patient with invasive ovarian cancer 5 years before diagnosis
  • Current pregnancy and lactation.
  • All social, medical, psychological, situations making the study impossible.
  • Person deprived of liberty.
Female
18 Years and older
No
Contact: MARAL Sylvie, UGEC Leader 33156245632 melanie.lebegue@curie.net
France
 
NCT01350908
IC2010-03
No
Mme Sylvie MARAL, INSTITUT CURIE
Institut Curie
Not Provided
Principal Investigator: LANTZ Olivier, MD Institut Curie
Institut Curie
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP