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出境医 / 临床实验 / Platino-resistance in Ovarian Cancer (PlatinOv)

Platino-resistance in Ovarian Cancer (PlatinOv)

Study Description
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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Platino-resistance in Ovarian Cancer
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : May 2029
Estimated Study Completion Date : May 2029
Arms and Interventions
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.
Outcome Measures
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 ]

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

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 who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Gwenaël FERRON 05 31 15 53 55 Ferron.Gwenael@iuct-oncopole.fr

Locations
Layout table for location information
France
Institut Universitaire du Cancer de Toulouse - Oncopole Recruiting
Toulouse, France
Contact: Gwenaël FERRON    05 31 15 53 55    Ferron.Gwenael@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE March 6, 2020
Estimated Primary Completion Date May 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		The rate of patients alive without progression [ Time Frame: 5 years for each patient ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		The time to onset of platinum based-chemotherapy resistance [ Time Frame: 5 years for each patient ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Platino-resistance in Ovarian Cancer
Official Title  ICMJE Platino-resistance in Ovarian Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Epithelial Ovarian Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Patients treated with platinum based-chemotherapy
Intervention: Other: Patients treated with platinum based-chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019) 		600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2029
Estimated Primary Completion Date May 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gwenaël FERRON 05 31 15 53 55 Ferron.Gwenael@iuct-oncopole.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954171
Other Study ID Numbers  ICMJE 19 GENF 01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Claudius Regaud
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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