Clinical trial NCT05752812: The HELPP Score: A Pretreatment Score to Predict Survival in Pancreatic Cancer
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic Ductal Adenocarcinoma
Pancreatic Resection
Preoperative Prognostic Score
Localized Non-Metastatic Pancreatic Ductal Adenocarcinoma
Recurrence
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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?

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.

Eligibility 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

Primary outcomes:
measure: Median overall survival
timeFrame: Date of diagnosis to date of death; assessed up to 60 months
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months
measure: Patterns of recurrence
timeFrame: Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna
Study officials:
affiliation: Medical University Vienna
name: Oliver Strobel, MD MBA
role: STUDY_DIRECTOR
References:
citation: Hank T, Hinz U, Reiner T, Malleo G, Konig AK, Maggino L, Marchegiani G, Kaiser J, Paiella S, Binco A, Salvia R, Hackert T, Bassi C, Buchler MW, Strobel O. A Pretreatment Prognostic Score to Stratify Survival in Pancreatic Cancer. Ann Surg. 2022 Dec 1;276(6):e914-e922. doi: 10.1097/SLA.0000000000004845. Epub 2021 Mar 4.