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
Information provided by:
Institut Curie Identifier:
First received: May 6, 2011
Last updated: May 9, 2011
Last verified: March 2011
Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Condition Intervention
Ovarian Cancer
Other: Blood sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer

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:
  • 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.

Estimated Enrollment: 25
Study Start Date: April 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01350908

Contact: MARAL Sylvie, UGEC Leader 33156245632

Institut Curie Recruiting
Paris, France, 75005
Contact: MARAL Sylvie, Leader UGEC    33156245632   
Sponsors and Collaborators
Institut Curie
Principal Investigator: LANTZ Olivier, MD Institut Curie
  More Information

Responsible Party: Mme Sylvie MARAL, INSTITUT CURIE Identifier: NCT01350908     History of Changes
Other Study ID Numbers: IC2010-03 
Study First Received: May 6, 2011
Last Updated: May 9, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms processed this record on May 26, 2016