Prognostic and Predictive Markers of Treatment Response in Patients With Pancreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,050
- 试验地点
- 15
- 主要终点
- Overall Survival (OS) rate
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,...) in patients with pancreatic adenocarcinoma. The effectiveness and tolerance of these treatments in current practice is also evaluated.
详细描述
The modest efficacy of current therapies for pancreatic cancer calls for the development of prognostic factors to guide patient selection and clinical decision-making based on tumor aggressiveness and risk of death.
The aim of this study is to identify prognostic and predictive factors of response to treatments administered in pancreatic adenocarcinoma, based on a multicenter cohort established on a population derived from current clinical practice. By accurately stratifying patients according to their estimated survival, prognostic tools could aid therapeutic decisions and optimize patient selection in future clinical trials.
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
- •Patient with histologically confirmed pancreatic adenocarcinoma.
- •Disease at a resectable, borderline, locally advanced, initially metastatic, or recurrent stage after surgery
- •Diagnosis between January 1, 2003, and December 31,
- •First-line treatment with chemotherapy and/or radiotherapy and/or clinical trials.
- •Age ≥ 18 years.
- •Written informed consent
排除标准
- •Patient under guardianship, curatorship, or judicial protection.
- •Pregnant or breastfeeding women.
- •Any medical, psychological, or social situation that could prevent compliance with the protocol as assessed by the investigator.
- •Refusal to participate in the study
结局指标
主要结局
Overall Survival (OS) rate
时间窗: Up to 7 years from the date of initial cancer diagnosis (or until death if it occurs before 17 years)
Defined as the time interval between the start date of treatment (surgery, first cycle of L1 chemotherapy, or first radiotherapy session) and the date of death regardless of the cause. Living or lost to follow-up patients will be censored at the date of the last news
次要结局
- Progression-free survival (PFS) rate(Up to 7 years)
- Number of patient with stability rate(Up to 7 years)
- Number of patient with grade 3/4 treatment-related toxicities(Up to 7 years)
- Number of patients who received maintenance treatment in the first-line(Up to 7 years)
- Number of patient with objective response rate(Up to 7 years)
- Number of patient with tumor progression(Up to 7 years)
- Number of patients who received second and third-line treatments(Up to 7 years)