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

July 20, 2016 updated by: Centre Francois Baclesse

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Institut de Cancerologie de La Loire
      • Paris, France, 75000
        • Institut Curie
    • Bretagne
      • Rennes, Bretagne, France, 35 000
        • Centre Eugene Marquis
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre François Baclesse
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44 000
        • Centre René Gauducheau
    • Nord
      • Lille, Nord, France, 59000
        • Centre Oscar Lambret
    • Seine Maritime
      • Rouen, Seine Maritime, France, 76 000
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Taxol and carboplatin
blood samples in patients receiving Taxol and carboplatin chemotherapy
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
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
Other: Taxol, carboplatin and avastin
blood samples in patients receiving Taxol, carboplatin chemotherapy with avastin
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
search for predictors of response to chemotherapy
Time Frame: 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
12 months after beginning treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
profiling miRNA expression
Time Frame: 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
1 month
study of changes in serum miRNA expression
Time Frame: 6 months
- The study of changes in serum miRNA expression identified as predictive of tumor response during chemotherapy treatment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • miRSa

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fallopian Tube Cancer

Clinical Trials on blood samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe