The HELPP Score: A Pretreatment Score to Predict Survival in Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatic Adenocarcinoma. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Median overall survival [Time frame: Date of diagnosis to date of death; assessed up to 60 months]
Secondary outcome measures (2)
- Recurrence-free survival [Time frame: Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months]
- Patterns of recurrence [Time frame: Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna — Vienna
Publications
- 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. PMID 33914468
Identifiers
NCT: NCT05752812 · MUVienna HELPP