Study of Circulating Tumoral DNA in Ovarian Cancer

Not Applicable

Completed

• Conditions: Ovarian Cancer
• Interventions: Other: Blood sampling

• Registration Number: NCT01350908
• Lead Sponsor: Institut Curie

Brief Summary

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

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.

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2015-01
• Study Completion: 2015-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sampling	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
Assessment and development of circulating tumor DNA detection techniques	2 years	Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.

Secondary Outcome Measures

Name	Time	Method
Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to feasibility, robustness, sensitivity and cost.	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.

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France