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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
| 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):
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 :
- The rate of patients alive without progression [ Time Frame: 5 years for each patient ]
Secondary Outcome Measures :
- The time to onset of platinum based-chemotherapy resistance [ Time Frame: 5 years for each patient ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Epithelial ovarian cancer at initial diagnosis (all stages)
- Curative treatment (exeresis surgery) not yet initiated excepted neo-adjuvant treatment
- Indication of platinum based-chemotherapy
- Patient affiliated to the french social security system
- Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure
Exclusion Criteria:
- Non-epithelial ovarian tumor, borderline ovarian tumor
- Patient with recurrent disease
- Exploratory surgery not performed at the "Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT-O)"
- Pregnant or breastfeeding women
- Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
- 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
| Contact: Gwenaël FERRON | 05 31 15 53 55 | Ferron.Gwenael@iuct-oncopole.fr |
Locations
| 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 |
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 |
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:
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):
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
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| 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 |
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| 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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