Marqueurs Pronostiques et prédictifs de réponse Aux Traitements Chez Les Patients Atteints de Cancer Des Voies Biliaires : Cohorte Multicentrique ACABi PRONOBIL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,350
- 试验地点
- 32
- 主要终点
- Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
研究概览
简要总结
The objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. The effectiveness and tolerance of these treatments in current practice will also be evaluated.
详细描述
Bile duct cancers are a heterogeneous group of rare tumors with a poor prognosis. Surgery is the only curative modality for localized forms. Chemotherapy is the standard treatment in advanced forms. Identification of prognostic and predictive markers to better stratify patients and to guide therapeutic decisions is a major issue. It is retro-prospective (diagnosis between 2003 and 2021) and prospective (diagnosis between 2021 and 2030) multi-center, cohort study. Follow-up for 10 years from initial cancer diagnosis will be done.
Follow-up is retrospective only for patients operated on or diagnosed in the past for more than 10 years, and retro-prospective for operated patients or diagnosed in the past for less than 10 years.
The data collected for each patient are available during the life cycle of this clinical trial to fulfil an educational requirement (e.g. a doctoral thesis) upon request and authorization from the study committee and the study sponsor (GERCOR).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All locations of primitives (intrahepatic CCA, extrahepatic CCA, adenocarcinoma of the gallbladder; ampullomas excluded)
- •Age > 18 years
- •Diagnosed between 2003 and 2030 (minimum follow-up 2 years)
- •Written written non-opposition +/- signed informed consent for genetic studies (N.B.:
- •exemption requested for a deceased patient) N.B. Authorized inclusion in a therapeutic research protocol
排除标准
- •Patient under guardianship, curatorship or legal protection
- •Pregnant or breastfeeding women
- •Any medical, psychological or social situation, which could prevent the compliance with the protocol according to the investigator's assessment
- •Refusal to participate in the study
结局指标
主要结局
Rate of patients with advanced bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months
时间窗: Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years)
Identification of clinical and tumor predictive factors of overall survival (OS) (prognostic markers) in patients with advanced bile duct cancer (BDC). OS defined as a period between the start of treatment and death, whatever the cause.
次要结局
- Toxicities (Adverse events) experienced by patients(Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years))
- Effects of treatments on disease-free survival (DFS)(Up to 10 years; The months between surgery and the first documented recurrence, second cancer, or death from any cause)
- Effects of treatments on progression-free survival (PFS)(Up to 10 years; The months between the start of treatment and the first progression or death, whatever be the cause)
- Rate of patients with localized bile duct cancer (BDC) experiencing overall survival (OS) less than 6 months(Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years))
- Response rate(Up to 10 years from the date of initial cancer diagnosis (or until death if it occurs before 10 years))
- Effect of treatments on secondary resection rate R0 of the primary tumor(From day of surgical intervention until 30 days)
- The complications and postoperative mortality rates in patients who underwent surgery(From day of surgical intervention until 30 days; up to 10 years)