Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT05752812
Status:
RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The HELPP Score: A Pretreatment Score to Predict Survival in Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median overall survival', 'timeFrame': 'Date of diagnosis to date of death; assessed up to 60 months', 'description': 'Median overall survival from the time of diagnosis with pancreatic ductal adenocarcinoma to time of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Recurrence-free survival', 'timeFrame': 'Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months', 'description': '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.'}, {'measure': 'Patterns of recurrence', 'timeFrame': 'Date of surgery to date of the first evidence of recurrent disease; assessed up to 60 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Ductal Adenocarcinoma', 'Pancreatic Resection', 'Preoperative Prognostic Score', 'Localized Non-Metastatic Pancreatic Ductal Adenocarcinoma', 'Recurrence'], 'conditions': ['Pancreatic Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '33914468', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* 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?\n* Is the HELPP score able to predict median recurrence-free survival and patterns of recurrence after resection of pancreatic cancer?', 'detailedDescription': '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.\n\nThe 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.\n\nThis 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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old\n* fit to undergo elective pancreatic resection or palliative therapy\n* localized non-metastatic pancreatic ductal adenocarcinoma\n* informed consent provided\n\nExclusion Criteria:\n\n* patients with a diagnosis other than pancreatic ductal adenocarcinoma on histopathology\n* missing informed consent\n* missing mandatory pretreatment laboratory values\n* missing mandatory pretreatment clinicopathologic data\n* patients receiving surgery for peripancreatic cancer\n* incomplete follow-up records\n* follow-up \\< 24 months\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT05752812', 'briefTitle': 'The HELPP Score: A Pretreatment Score to Predict Survival in Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MUVienna HELPP'}}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Carl Leonhardt', 'role': 'CONTACT', 'email': 'carl-stephan.leonhardt@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '56470'}, {'name': 'Carl Leonhardt, MD, MBA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Oliver Strobel, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of General Surgery, Division of Visceral Surgery, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Carl Leonhardt, MD MBA', 'role': 'CONTACT', 'email': 'carl-stephan.leonhardt@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '56470'}], 'overallOfficials': [{'name': 'Oliver Strobel, MD MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. , MBA', 'investigatorFullName': 'Oliver Strobel, MD MBA', 'investigatorAffiliation': 'Medical University of Vienna'}}}}