Study of Circulating Tumoral DNA in Ovarian Cancer

Institut Curie

Status: Completed

Conditions: Ovarian Cancer

Treatments: Other: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT01350908

IC2010-03

Details and patient eligibility

About

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

Full 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.

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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Blood sampling

Other group

Treatment:

Other: Blood sampling