The HELPP Score: A Pretreatment Prognostic Score to Predict Survival and Patterns of Recurrence in Localized Non-Metastatic Pancreatic Cancer - a Multicenter Prospective Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Median overall survival
研究概览
简要总结
The goal of this observational study is to validate a pretreatment prognostic score (Heidelberg Prognostic Pancreatic Cancer Score - HELPP) in patients with pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
- Is the HELPP score able to predict median overall survival in a prospective multi-institutional cohort of patients with pretherapeutic localized non-metastatic pancreatic cancer?
- Is the HELPP score able to predict median recurrence-free survival and patterns of recurrence after resection of pancreatic cancer?
详细描述
Accurate pretreatment staging and subsequent prediction of prognosis in pancreatic ductal adenocarcinoma (PDAC) is challenging due to subclinical micrometastasis as well as variations in tumor biology. Moreover, patients with non-metastasized localized PDAC are increasingly treated with neoadjuvant chemotherapy prior to resection.
The investigators recently developed a preoperative prognostic score to predict postoperative outcomes based on routine laboratory biomarkers and the American Society of Anesthesiologists (ASA) score, the HELPP score (Heidelberg Prognostic Pancreatic Cancer Score). Based on a large retrospective analysis of 1197 patients and an external validation cohort the HELPP score was able stratify patients based on expected survival only utilizing routinely available preoperative data. However, prospective validation is currently lacking.
This multi-site prospective observational study aims to prospectively validate the HELPP score in the clinical scenarios described above. Additionally, it aims to investigate its utility regarding median recurrence-free survival and patterns of recurrence. The study includes all consecutive patients with PDAC undergoing exploration (without or without neoadjuvant treatment) with the aim of resection within a timeframe of 12 months (all-comers concept, snapshot study).
The parameters on which the score is based on are routinely available to hospitals worldwide. Simplicity of the grading system facilitates implementation in daily clinical practice. This score could potentially help tailor treatments, aid in patient stratification in clinical trials, and provide new insights into tumor biology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •fit to undergo elective pancreatic resection or palliative therapy
- •localized non-metastatic pancreatic ductal adenocarcinoma
- •informed consent provided
排除标准
- •patients with a diagnosis other than pancreatic ductal adenocarcinoma on histopathology
- •missing informed consent
- •missing mandatory pretreatment laboratory values
- •missing mandatory pretreatment clinicopathologic data
- •patients receiving surgery for peripancreatic cancer
- •incomplete follow-up records
- •follow-up < 24 months
- •pregnancy
结局指标
主要结局
Median overall survival
时间窗: Date of diagnosis to date of death; assessed up to 60 months
Median overall survival from the time of diagnosis with pancreatic ductal adenocarcinoma to time of death due to any cause.
次要结局
- Recurrence-free survival(Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months)
- Patterns of recurrence(Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months)
研究者
Oliver Strobel, MD MBA
Prof. Dr. , MBA
Medical University of Vienna