Carcinoma of the Ovary, Fallopian Tube Cancer, Peritoneal Serous-type Advanced Stage
Conditions
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)
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).
Interventions
OTHERblood 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
Sponsors
Centre Francois Baclesse
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| search for predictors of response to chemotherapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| profiling miRNA expression | 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 |
| study of changes in serum miRNA expression | 6 months | \- The study of changes in serum miRNA expression identified as predictive of tumor response during chemotherapy treatment. |
Countries
France
Outcome results
None listed