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

NCT05752812 | Recruiting

• 1 other identifier: MUVienna HELPP
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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?

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic Ductal Adenocarcinoma; Pancreatic Resection; Preoperative Prognostic Score; Localized Non-Metastatic Pancreatic Ductal Adenocarcinoma; Recurrence

Outcome Measures

Primary Outcomes (1)

• Median overall survival

  Median overall survival from the time of diagnosis with pancreatic ductal adenocarcinoma to time of death due to any cause.

  Date of diagnosis to date of death; assessed up to 60 months

Secondary Outcomes (2)

• Recurrence-free survival

  Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months

• Patterns of recurrence

  Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥18 years old
• fit to undergo elective pancreatic resection or palliative therapy
• localized non-metastatic pancreatic ductal adenocarcinoma
• informed consent provided

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oliver Strobel, MD MBA

  Medical University Vienna

  STUDY DIRECTOR

Central Study Contacts

Carl Leonhardt, MD MBA

CONTACT

+43140400; carl-stephan.leonhardt@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. , MBA

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: March 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)