JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT05752812

Studienbeginn:
März 2023

Letztes Update:
27.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Adenocarcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Vienna

Collaborator:
-

Studienleiter

Oliver Strobel, MD MBA
Study Director
Medical University Vienna

Kontakt

Carl Leonhardt, MD MBA
Kontakt:
Phone: +43140400
Phone (ext.): 56470
E-Mail: carl-stephan.leonhardt@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Carl Leonhardt
Phone: +43140400
Phone (ext.): 56470
E-Mail: carl-stephan.leonhardt@meduniwien.ac.at» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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.

Secondary outcome:

1. 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.

2. 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.

Quelle: ClinicalTrials.gov

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