The HELPP Score: A Pretreatment Score to Predict Survival in Pancreatic Cancer
NCT ID: NCT05752812
Last Updated: 2023-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2023-03-01
2026-11-30
Brief Summary
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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?
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* fit to undergo elective pancreatic resection or palliative therapy
* localized non-metastatic pancreatic ductal adenocarcinoma
* informed consent provided
Exclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Oliver Strobel, MD MBA
Prof. Dr. , MBA
Principal Investigators
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Oliver Strobel, MD MBA
Role: STUDY_DIRECTOR
Medical University Vienna
Locations
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Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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MUVienna HELPP
Identifier Type: -
Identifier Source: org_study_id
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