The HELPP Score: A Pretreatment Score to Predict Survival... | NCT05752812

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

NCT05752812

Sponsor

Medical University of Vienna

Status

Recruiting

Last Update Posted

Oct 27, 2023Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Pancreatic Adenocarcinoma

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

May 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Feb 21, 2023

First Submission Date that Met QC Criteria

Feb 21, 2023

First Posted Date

Mar 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2023

Last Update Posted Date

Oct 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oliver Strobel, MD MBA, Prof. Dr. , MBA, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carl Leonhardt, MD MBA	Contact	+43140400	56470	carl-stephan.leonhardt@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Oliver Strobel, MD MBA	Medical University Vienna	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna	Recruiting	Vienna		1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33914468	Background	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms