Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
| Sponsors |
Lead Sponsor: Institut Curie |
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| Source | Institut Curie | |||||||||||||||||||||||||
| Brief Summary | Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points. |
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| Overall Status | Active, not recruiting | |||||||||||||||||||||||||
| Start Date | July 2013 | |||||||||||||||||||||||||
| Completion Date | December 2019 | |||||||||||||||||||||||||
| Primary Completion Date | July 2019 | |||||||||||||||||||||||||
| Phase | N/A | |||||||||||||||||||||||||
| Study Type | Interventional | |||||||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 419 | |||||||||||||||||||||||||
| Condition | ||||||||||||||||||||||||||
| Intervention |
Intervention Type: Procedure Intervention Name: Tumor biopsies Description: Tumor biopsies will be performed before and after treatment. Arm Group Label: Tumor biopsies and blood sampling Intervention Type: Procedure Intervention Name: Blood sampling Description: Blood sampling will be performed before and after treatment. Arm Group Label: Tumor biopsies and blood sampling |
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| Eligibility |
Criteria:
Inclusion Criteria: 1. No prior treatment for cervical cancer. 2. FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type). 3. Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB2. and optional for IB1 stage 4. Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more). 5. Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment). 6. Age ≥ 18 years. 7. ECOG (Eastern Cooperative Oncology Group) 0-2. 8. Life expectancy > 6 months. 9. Patient eligible for standard treatment (according to standards of each center). 10. Patient having health care insurance. 11. Informed and signed consent by patient. (DICOM = Digital Imaging and Communications in Medicine) Exclusion Criteria: 1. Patient enrolled in a clinical trial involving an investigative new agent. 2. Co morbidity, preventing patient to tolerate the proposed standard treatment. 3. Past history of invasive cancer over the 5 years preceding entry in the present trial (except basal cell carcinoma and carcinoma in situ of the cervix). 4. Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 . 5. Patient deprived from ability to decide on her own. 6. Patient unable to have a regular follow up for geographical, social or psychological reasons. 7. Pregnancy or patient old enough to procreate and not using effective contraceptive method. Gender: Female Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
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| Location |
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| Location Countries |
France Germany Netherlands Romania Serbia |
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| Verification Date |
October 2019 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | |||||||||||||||||||||||||
| Condition Browse | ||||||||||||||||||||||||||
| Number Of Arms | 1 | |||||||||||||||||||||||||
| Arm Group |
Label: Tumor biopsies and blood sampling Type: Other Description: Patient will undergo standard care with tumor and blood sampling before and after treatment. Blood and tumor sampling will also be performed at disease progression/relapse. |
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| Acronym | BIO-RAIDs | |||||||||||||||||||||||||
| Study Design Info |
Allocation: N/A Intervention Model: Single Group Assignment Primary Purpose: Basic Science Masking: None (Open Label) |
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