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Pancreatic AdenocarcinomaNCT05752812

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

An observational study of Pancreatic Adenocarcinoma, run by Medical University of Vienna at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Pancreatic Adenocarcinoma
How many people
1,500 participants
Where
1 siteAustria
Study dates
1 Mar 2023to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carl Leonhardt, MD MBA contact

+43140400 ext. 56470

carl-stephan.leonhardt@meduniwien.ac.at

Austria1 site, 1 recruiting

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

    Vienna, 1090

    Carl Leonhardt, +43140400 ext. 56470, carl-stephan.leonhardt@meduniwien.ac.at

    Carl Leonhardt, MD, MBA

    Recruiting

Other trials in Austria

About this study

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

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?
Read the 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.

Keywords
Pancreatic Ductal Adenocarcinoma, Pancreatic Resection, Preoperative Prognostic Score, Localized Non-Metastatic Pancreatic Ductal Adenocarcinoma, Recurrence
Medical subject headings
Recurrence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median overall survival

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

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

Secondary outcomes (2)

  1. Recurrence-free survival

    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.

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

  2. Patterns of recurrence

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start1 Mar 2023
  3. Primary completionMay 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05752812
Sponsor's protocol ID
MUVienna HELPP
Status last verified
Oct 2023
First submitted
21 Feb 2023
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33914468

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Adenocarcinoma, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carl Leonhardt, MD MBA (+43140400 ext. 56470, carl-stephan.leonhardt@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median overall survival (time frame: Date of diagnosis to date of death; assessed up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05752812, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.

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