Search for Predictors of Therapeutic Response in Ovarian Carcinoma

Study Overview
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Brief Summary
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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).

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

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

Intervention / Treatment
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* Other: blood samples
* Other: blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Taxol and carboplatin<br>blood samples in patients receiving Taxol and carboplatin chemotherapy | Other: blood samples<br>* 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<br>|
| Other: Taxol, carboplatin and avastin<br>blood samples in patients receiving Taxol, carboplatin chemotherapy with avastin | Other: blood samples<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)