NCT05752812

The HELPP Score: A Pretreatment Score to Predict Survival in Pancreatic Cancer

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

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.

Conditions

• Pancreatic Adenocarcinoma

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2023-03-03
• Last updated: 2023-10-27

Locations

1 site across 1 country: Austria