Study of Circulating Tumoral DNA in Ovarian Cancer

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. Identifier: NCT01350908
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):
Institut Curie

May 6, 2011
May 10, 2011
January 23, 2017
April 2011
January 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01350908 on 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 ]
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.


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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Blood sampling
Intervention: Other: Blood sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2015
January 2015   (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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Institut Curie
Institut Curie
Not Provided
Principal Investigator: LANTZ Olivier, MD Institut Curie
Institut Curie
July 2016

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