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Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer

18 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

Development and Validation of a Circulating Tumor DNA Detection Technique 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.

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Assessment and development of circulating tumor DNA detection techniques

Outcome Description:

Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

LANTZ Olivier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Curie


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

April 2011

Completion Date:

April 2012

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms