Search for Predictors of Therapeutic Response in Ovarian Carcinoma

NCT01391351 | Completed

• 1 other identifier: miRSa
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 7

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).

Conditions

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

Keywords

carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage; chemotherapy with Taxol and Carboplatin; predictors of therapeutic response; serum miRNA; identification of polymorphisms or SNPs (Single Nucleotide Polymorphism)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• profiling miRNA expression

  1 month

• study of changes in serum miRNA expression

  6 months

Study Arms (2)

Taxol and carboplatin

OTHER

blood samples in patients receiving Taxol and carboplatin chemotherapy

Other: blood samples

Taxol, carboplatin and avastin

OTHER

blood samples in patients receiving Taxol, carboplatin chemotherapy with avastin

Other: blood samples

Interventions

blood samples 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 and carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (7)

Centre Eugène Marquis

Rennes, Brittany Region, 35 000, France

Location

Centre François BACLESSE

Caen, Calvados, 14076, France

Location

Centre Réné Gauducheau

Nantes, Loire-Atlantique, 44 000, France

Location

Centre Oscar LAMBRET

Lille, Nord, 59000, France

Location

Centre Henri Becquerel

Rouen, Seine Maritime, 76 000, France

Location

Institut de cancerologie de la loire

Angers, 49000, France

Location

Institut CURIE

Paris, 75000, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Florence JOLY-LOBBEDEZ, PD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

• Sophie KRIEGER, MD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: July 1, 2016
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

FR (7)