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

October 25, 2023 updated by: Oliver Strobel, MD MBA, Medical University of Vienna

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

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?

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna
        • Contact:
        • Sub-Investigator:
          • Carl Leonhardt, MD, MBA
        • Principal Investigator:
          • Oliver Strobel, MD, MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median overall survival
Time Frame: 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.
Date of diagnosis to date of death; assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 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.
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
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.
Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Study Director: Oliver Strobel, MD MBA, Medical University Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUVienna HELPP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Adenocarcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe