Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer
18 Years
N/A
Female
Ovarian Cancer
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.
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.
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:
Interventional
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:
No
Principal Investigator
LANTZ Olivier, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Curie
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IC2010-03
NCT ID:
NCT01350908
Start Date:
April 2011
Completion Date:
April 2012
Related Keywords:
- Ovarian Cancer
- Ovarian Neoplasms
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