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NCT Number: NCT01391351

Search for Predictors of Therapeutic Response in Ovarian Carcinoma

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).

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Key information

Conditions

Carcinoma of the Ovary Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Serous-type Advanced Stage Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Eugène Marquis, Rennes, Brittany Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. profiling miRNA expression

    Time frame: 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

  2. study of changes in serum miRNA expression

    Time frame: 6 months

    • The study of changes in serum miRNA expression identified as predictive of tumor response during chemotherapy treatment.

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Official study title

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

Acronym: miRSa

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jul 12, 2011
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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