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

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

NCT ID: NCT05752812

Condition: Pancreatic Adenocarcinoma

Conditions: Official terms:
Adenocarcinoma

Conditions: Keywords:
Pancreatic Ductal Adenocarcinoma
Pancreatic Resection
Preoperative Prognostic Score
Localized Non-Metastatic Pancreatic Ductal Adenocarcinoma
Recurrence

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
All consecutive patients presenting with localized non-metastatic pancreatic ductal adenocarcinoma undergoing treatment (upfront resection, resection after neoadjuvant therapy, or palliative therapy) at participating centers.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - ≥18 years old - fit to undergo elective pancreatic resection or palliative therapy - localized non-metastatic pancreatic ductal adenocarcinoma - informed consent provided Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna

Address:
City: Vienna
Zip: 1090
Country: Austria

Status: Recruiting

Contact:
Last name: Carl Leonhardt

Phone: +43140400

Phone ext: 56470
Email: carl-stephan.leonhardt@meduniwien.ac.at

Investigator:
Last name: Carl Leonhardt, MD, MBA
Email: Sub-Investigator

Investigator:
Last name: Oliver Strobel, MD, MBA
Email: Principal Investigator

Start date: March 1, 2023

Completion date: November 2026

Lead sponsor:
Agency: Medical University of Vienna
Agency class: Other

Source: Medical University of Vienna

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05752812