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Platino-resistance in Ovarian Cancer (PlatinOv)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03954171
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:

Prospective, monocentric study aiming to identify factors involved in platinum based-chemotherapy resistance in patients with epithelial ovarian cancer (all stages).

Patients will receive treatment (platinum based-chemotherapy) according to the standard practices.

A prospective database and an associated biological collection will be performed during 5 years:

  • For each patient: clinical, biological, epidemiological and therapeutic treatment data will be collected during the standard therapeutic care.
  • Biological samples (blood samples, tumor biopsy specimens and ascites samples) will be collected for all patients. These samples will be collected at the same time as those taken in standard practice (no additional biopsy will be performed for the study).

Study participation of each patient will be 5 years.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Other: Patients treated with platinum based-chemotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Platino-resistance in Ovarian Cancer
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2029
Estimated Study Completion Date : May 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Patients treated with platinum based-chemotherapy Other: Patients treated with platinum based-chemotherapy

Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice):

  • before treatment initiation (blood sample),
  • during hospitalisation for surgery (blood sample),
  • during follow-up consultations (blood sample).

If tumor biopsy and/or ascites sampling are performed during the standard care, a sample will be collected for the study.

Primary Outcome Measures :
  1. The rate of patients alive without progression [ Time Frame: 5 years for each patient ]

Secondary Outcome Measures :
  1. The time to onset of platinum based-chemotherapy resistance [ Time Frame: 5 years for each patient ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Epithelial ovarian cancer at initial diagnosis (all stages)
  3. Curative treatment (exeresis surgery) not yet initiated excepted neo-adjuvant treatment
  4. Indication of platinum based-chemotherapy
  5. Patient affiliated to the french social security system
  6. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure

Exclusion Criteria:

  1. Non-epithelial ovarian tumor, borderline ovarian tumor
  2. Patient with recurrent disease
  3. Exploratory surgery not performed at the "Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT-O)"
  4. Pregnant or breastfeeding women
  5. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
  6. Patient protected by law

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03954171

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Contact: Gwenaël FERRON 05 31 15 53 55

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Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
Contact: Gwenaël FERRON    05 31 15 53 55   
Sponsors and Collaborators
Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud Identifier: NCT03954171    
Other Study ID Numbers: 19 GENF 01
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Epithelial Ovarian Cancer
Platinum based-chemotherapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents