Search for Predictors of Therapeutic Response in Ovarian Carcinoma

NCT ID: NCT01391351

Last Updated: 2016-07-21

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

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-07-31

Brief Summary

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In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).

Detailed Description

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Conditions

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Carcinoma of the Ovary Fallopian Tube Cancer Peritoneal Serous-type Advanced Stage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Taxol and carboplatin

blood samples in patients receiving Taxol and carboplatin chemotherapy

Group Type OTHER

blood samples

Intervention Type OTHER

blood samples in patients receiving Taxol and carboplatin chemotherapy :

* On Day 1 of the first course of chemotherapy
* On Day 1 of the second course of chemotherapy
* Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy
* At the end of chemotherapy

Taxol, carboplatin and avastin

blood samples in patients receiving Taxol, carboplatin chemotherapy with avastin

Group Type OTHER

blood samples

Intervention Type OTHER

blood samples in patients receiving Taxol and carboplatin chemotherapy with avastin:

* On Day 1 of the first course of chemotherapy
* On Day 1 of the second course of chemotherapy
* Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy
* At the end of chemotherapy

Interventions

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blood samples

blood samples in patients receiving Taxol and carboplatin chemotherapy :

* On Day 1 of the first course of chemotherapy
* On Day 1 of the second course of chemotherapy
* Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy
* At the end of chemotherapy

Intervention Type OTHER

blood samples

blood samples in patients receiving Taxol and carboplatin chemotherapy with avastin:

* On Day 1 of the first course of chemotherapy
* On Day 1 of the second course of chemotherapy
* Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy
* At the end of chemotherapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with cancer of the ovary, peritoneum or of the fallopian tube
* Stage III or IV
* Cancer of serous histology
* Patients of any chemotherapy naive
* Patients should receive treatment with chemotherapy for first line by Taxol- Carboplatin. Avastin is authorized in concomitant.
* An initial surgery or through authorized
* Patients who signed informed consent
* Patients over the age of 18 years

Exclusion Criteria

* Patients being treated for another cancer chemotherapy and / or hormone therapy
* Patients receiving other chemotherapy Taxol-carboplatin associated or not to avastin
* Patients under guardianship
* Previous history of pelvic radiotherapy
* History of malignancy blood
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence JOLY-LOBBEDEZ, PD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Sophie KRIEGER, MD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Locations

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Centre Eugène Marquis

Rennes, Brittany Region, France

Site Status

Centre François BACLESSE

Caen, Calvados, France

Site Status

Centre Réné Gauducheau

Nantes, Loire-Atlantique, France

Site Status

Centre Oscar LAMBRET

Lille, Nord, France

Site Status

Centre Henri Becquerel

Rouen, Seine Maritime, France

Site Status

Institut de cancerologie de la loire

Angers, , France

Site Status

Institut CURIE

Paris, , France

Site Status

Countries

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France

Other Identifiers

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miRSa

Identifier Type: -

Identifier Source: org_study_id

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