NCT02428842已完成不适用
Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 24
- 主要终点
- Correlation between tumor biological profile and treatment response.
研究概览
简要总结
Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •No prior treatment for cervical cancer.
- •FIGO Stage IB1 to IVB; all histological subtypes (excluding neuro-endocrine type).
- •Pelvic MRI available or planned before the start of treatment, , if FIGO ≥ IB
- •and optional for IB1 stage
- •Possibility to communicate imaging data by CD-ROM (format DICOM 3.0 or more).
- •Disease amenable to biopsy (3 tumour samples are mandatory prior to treatment).
- •Age ≥ 18 years.
- •ECOG (Eastern Cooperative Oncology Group) 0-
- •Life expectancy > 6 months.
- •Patient eligible for standard treatment (according to standards of each center).
- •Patient having health care insurance.
- •Informed and signed consent by patient.
- •(DICOM = Digital Imaging and Communications in Medicine)
排除标准
- •Patient enrolled in a clinical trial involving an investigative new agent.
- •Co morbidity, preventing patient to tolerate the proposed standard treatment.
- •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).
- •Impossibility to carry out evaluation by MRI (patient claustrophobic, pacemaker, metallic implant, non availability, other), ), if FIGO ≥ IB2 .
- •Patient deprived from ability to decide on her own.
- •Patient unable to have a regular follow up for geographical, social or psychological reasons.
- •Pregnancy or patient old enough to procreate and not using effective contraceptive method.
研究组 & 干预措施
Tumor biopsies and blood sampling
Other
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.
干预措施: Tumor biopsies (Procedure)
Tumor biopsies and blood sampling
Other
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.
干预措施: Blood sampling (Procedure)
结局指标
主要结局
Correlation between tumor biological profile and treatment response.
时间窗: up to 6 months
Dominant mutations and activation pathways in cervical cancers is assessed from tumor biopsies.
次要结局
- Progression Free Survival evaluation(up to 18 months)
- Standard treatment description (Description of primary treatment course regarding : - Initial FIGO ( International Federation of Gynecology and Obstetrics ) staging at baseline - Geographic location(country)(up to six months)
- Standard treatment's side effects description (assessed by compiling grade 3 and 4 sides effects during and after treatment (according to NCI CTCAE v4.03 scale - National Cancer Institute Common Toxicity Criteria for Adverse Effects)(up to 6 months)
- Molecular tumor alterations description (Description of molecular tumor alterations regarding geographic location (country)(up to 24 months)
研究者
研究点 (24)
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