Predicting survival in pancreatic cancer using the HELPP score
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
Medical University of Vienna · NCT05752812
This study is testing a new scoring system called the HELPP score to see if it can better predict survival and recurrence for patients with early-stage pancreatic cancer before they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05752812 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the HELPP score, a preoperative prognostic tool designed to predict survival outcomes in patients with localized non-metastatic pancreatic ductal adenocarcinoma. The study will assess the HELPP score's ability to forecast median overall survival and recurrence-free survival in a prospective multi-institutional cohort. By utilizing routinely available laboratory biomarkers and clinical data, the HELPP score seeks to improve the accuracy of pre-treatment staging and prognosis. The study will include all consecutive patients undergoing exploration for potential resection within a 12-month timeframe.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with localized non-metastatic pancreatic ductal adenocarcinoma who are fit for elective surgery.
Not a fit: Patients with other types of cancer or those who do not meet the eligibility criteria, such as missing informed consent or mandatory laboratory values, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting survival outcomes in pancreatic cancer patients, aiding in treatment planning.
How similar studies have performed: While the HELPP score has shown promise in retrospective analyses, this prospective validation is novel and has not been previously tested in this manner.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna — Vienna, Austria (RECRUITING)
Study contacts
- Study coordinator: Carl Leonhardt, MD MBA
- Email: carl-stephan.leonhardt@meduniwien.ac.at
- Phone: +43140400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Resection, Preoperative Prognostic Score, Localized Non-Metastatic Pancreatic Ductal Adenocarcinoma, Recurrence