Search for Predictors of Therapeutic Response in Ovarian Carcinoma (miRSa)

This study is currently recruiting participants.

Verified April 2013 by Centre Francois Baclesse

Sponsor:

Information provided by (Responsible Party):

Centre Francois Baclesse

ClinicalTrials.gov Identifier:

NCT01391351

First received: July 8, 2011

Last updated: April 18, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2011

Last Updated Date

April 18, 2013

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

search for predictors of response to chemotherapy [ Time Frame: 12 months after beginning treatment ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01391351 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

profiling miRNA expression [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The study of changes in serum miRNA expression identified as predictive of tumor response during chemotherapy treatment.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Search for Predictors of Therapeutic Response in Ovarian Carcinoma

Official Title ^ICMJE

Search for Predictors of Therapeutic Response in Patients With Carcinoma of the Ovary, the Fallopian Tube or Peritoneal Serous-type Advanced

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

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

Intervention ^ICMJE

Other: 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

Study Arm (s)

Taxol and carboplatin

blood samples in patients receiving Taxol and carboplatin chemotherapy

Intervention: Other: blood samples

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

March 2015

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Florence JOLY-LOBBEDEZ, PD	02 31 45 50 02	f.joly@baclesse.fr
Contact: Stépanie LHEUREX, MD	02 31 45 50 02	s.lheureux@baclesse.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01391351

Other Study ID Numbers ^ICMJE

miRSa

Has Data Monitoring Committee

Responsible Party

Centre Francois Baclesse

Study Sponsor ^ICMJE

Centre Francois Baclesse

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Florence JOLY-LOBBEDEZ, PD	Centre François Baclesse
Principal Investigator:	Sophie KRIEGER, MD	Centre François Baclesse

Information Provided By

Centre Francois Baclesse

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top