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

Sponsor

Medical University of Vienna (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05752812

Collaborator

(none)

1,500

Enrollment

Location

42.1

Anticipated Duration (Months)

35.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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?

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Adenocarcinoma

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

Nov 1, 2026

Outcome Measures

Primary Outcome Measures

Median overall survival [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.

Secondary Outcome Measures

Recurrence-free survival [Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months]
Median recurrence-free survival from the date of potentially curative pancreatic surgery for pancreatic ductal adenocarcinoma until detection of the first evidence of recurrent disease either based on cross-sectional imaging or cytology/histology.
Patterns of recurrence [Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months]
Patterns of recurrence either based on cross-sectional imaging or cytology/histology after potentially curative pancreatic surgery of pancreatic ductal adenocarcinoma. The location of recurrence will be defined based on the first site of recurrence. Only the first site of recurrence will be considered.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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