Study of Circulating Tumoral DNA in Ovarian Cancer

NCT ID: NCT01350908

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Blood sampling

Group Type OTHER

Blood sampling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LANTZ Olivier, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

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Institut Curie

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IC2010-03

Identifier Type: -

Identifier Source: org_study_id

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