Clinical trial NCT01391351: Search for Predictors of Therapeutic Response in Ovarian Carcinoma
Official title: Search for Predictors of Therapeutic Response in Patients With Carcinoma of the Ovary, the Fallopian Tube or Peritoneal Serous-type Advanced
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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).


Eligibility criteria: 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

Primary outcomes:
measure: search for predictors of response to chemotherapy
timeFrame: 12 months after beginning treatment
Secondary outcomes:
measure: profiling miRNA expression
timeFrame: 1 month
measure: study of changes in serum miRNA expression
timeFrame: 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Eugène Marquis
state: Bretagne
city: Caen
country: France
facility: Centre François BACLESSE
state: Calvados
city: Nantes
country: France
facility: Centre Réné Gauducheau
state: Loire-Atlantique
city: Lille
country: France
facility: Centre Oscar LAMBRET
state: Nord
city: Rouen
country: France
facility: Centre Henri Becquerel
state: Seine Maritime
city: Angers
country: France
facility: Institut de cancerologie de la loire
city: Paris
country: France
facility: Institut CURIE
Study officials:
affiliation: Centre François Baclesse
name: Florence JOLY-LOBBEDEZ, PD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre François Baclesse
name: Sophie KRIEGER, MD
role: PRINCIPAL_INVESTIGATOR
References: