Search for Predictors of Therapeutic Response in Ovarian Carcinoma

Fallopian Tube Cancer Clinical Trial

— miRSa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391351
• Other study ID #: miRSa
• Status: Completed
• Phase: N/A
• First received: July 8, 2011
• Last updated: July 20, 2016
• Start date: June 2011
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma of the Ovary
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Peritoneal Serous-type Advanced Stage

Intervention

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
• 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

Locations

Country	Name	City	State
France	Institut de cancerologie de la loire	Angers
France	Centre François BACLESSE	Caen	Calvados
France	Centre Oscar LAMBRET	Lille	Nord
France	Centre Réné Gauducheau	Nantes	Loire-Atlantique
France	Institut CURIE	Paris
France	Centre Eugène Marquis	Rennes	Bretagne
France	Centre Henri Becquerel	Rouen	Seine Maritime

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	search for predictors of response to chemotherapy	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	No
Secondary	profiling miRNA expression	- 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	No
Secondary	study of changes in serum miRNA expression	- The study of changes in serum miRNA expression identified as predictive of tumor response during chemotherapy treatment.	6 months	No