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Clinical Trials/NCT01391351
NCT01391351
Completed
Not Applicable

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

Centre Francois Baclesse7 sites in 1 country107 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carcinoma of the Ovary
Sponsor
Centre Francois Baclesse
Enrollment
107
Locations
7
Primary Endpoint
search for predictors of response to chemotherapy
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Centre Francois Baclesse
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

search for predictors of response to chemotherapy

Time Frame: 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 Outcomes

  • profiling miRNA expression(1 month)
  • study of changes in serum miRNA expression(6 months)

Study Sites (7)

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