Search for Predictors of Therapeutic Response in Ovarian Carcinoma

Not Applicable

Completed

• Conditions: Carcinoma of the Ovary; Fallopian Tube Cancer; Peritoneal Serous-type Advanced Stage
• Interventions: Other: blood samples

• Registration Number: NCT01391351
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Primary Completion: 2015-11
• Status Verified: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taxol, carboplatin and avastin	blood samples	blood samples in patients receiving Taxol, carboplatin chemotherapy with avastin
Taxol and carboplatin	blood samples	blood samples in patients receiving Taxol and carboplatin chemotherapy

Primary Outcome Measures

Name	Time	Method
search for predictors of response to chemotherapy	12 months after beginning treatment	the search for predictors of response to chemotherapy in patients with carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced by using (i) the miRNA profile of serum before treatment with chemotherapy and (ii) the identification of polymorphisms or SNPs (Single Nucleotide polymorphism) in particular genes involved in the metabolism of chemotherapy agents

Secondary Outcome Measures

Name	Time	Method
profiling miRNA expression	1 month	- Characterization of the response to treatment with profiling miRNA expression after the first course of chemotherapy in patients with carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced
study of changes in serum miRNA expression	6 months	- The study of changes in serum miRNA expression identified as predictive of tumor response during chemotherapy treatment.

Trial Locations

Locations (7)

Institut de cancerologie de la loire; 🇫🇷 Angers, France

Centre Oscar LAMBRET; 🇫🇷 Lille, Nord, France

Institut CURIE; 🇫🇷 Paris, France

Centre François BACLESSE; 🇫🇷 Caen, Calvados, France

Centre Henri Becquerel; 🇫🇷 Rouen, Seine Maritime, France

Centre Eugène Marquis; 🇫🇷 Rennes, Bretagne, France

Centre Réné Gauducheau; 🇫🇷 Nantes, Loire-Atlantique, France