Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 7:35 PM
Study NCT ID:
NCT02089269
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2014-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Registry Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2325}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2014-03-14', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment reality in Germany', 'timeFrame': 'over 5 years', 'description': 'description of treatments selected for patients per line of therapy over the course of the project'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pancreatic neoplasms', 'neoplasms', 'registry', 'advanced pancreatic cancer', 'health services research', 'epidemiology', 'Germany', 'palliative treatment', 'palliative care', 'localized, resectable pancreatic cancer', 'adjuvant treatment'], 'conditions': ['Pancreas Cancer']}, 'referencesModule': {'references': [{'pmid': '30006989', 'type': 'BACKGROUND', 'citation': 'Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Janicke M, Marschner N; TPK-Group (Tumour Registry Pancreatic Cancer). Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Int J Cancer. 2019 Mar 1;144(5):981-990. doi: 10.1002/ijc.31751. Epub 2018 Oct 3.'}, {'pmid': '36053905', 'type': 'BACKGROUND', 'citation': 'Marschner N, Hegewisch-Becker S, Reiser M, von der Heyde E, Bertram M, Hollerbach SH, Kreher S, Wolf T, Binninger A, Chiabudini M, Kaiser-Osterhues A, Janicke M; TPK-Group (Tumour Registry Pancreatic Cancer). FOLFIRINOX or gemcitabine/nab-paclitaxel in advanced pancreatic adenocarcinoma: A novel validated prognostic score to facilitate treatment decision-making in real-world. Int J Cancer. 2023 Feb 1;152(3):458-469. doi: 10.1002/ijc.34271. Epub 2022 Sep 22.'}, {'pmid': '38956837', 'type': 'BACKGROUND', 'citation': 'Marschner N, Haug N, Hegewisch-Becker S, Reiser M, Dorfel S, Lerchenmuller C, Linde H, Wolf T, Hof A, Kaiser-Osterhues A, Potthoff K, Janicke M; TPK-Group (Tumour Registry Pancreatic Cancer). Head-to-head comparison of treatment sequences in advanced pancreatic cancer-Real-world data from the prospective German TPK clinical cohort study. Int J Cancer. 2024 Nov 1;155(9):1629-1640. doi: 10.1002/ijc.35071. Epub 2024 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'The registry aims to collect and analyse information on the antineoplastic treatment of patients with unresectable locally advanced or metastatic pancreatic cancer, treated in palliative intention (cohort 1) and patients with localized, resectable pancreatic cancer treated in neo-adjuvant or adjuvant intention (cohort 2) in daily routine practice in Germany. The registry will follow up patients for two years. It will identify common sequences of treatments used as well as changes in the treatment of the disease. Health-related quality of life will be analysed during the course of the treatment (PanLife). Based on the available data a prognostic score will be developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pancreatic cancer undergoing antineoplastic treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* resectable or locally advanced/metastatic pancreatic cancer\n* 18 years and older\n* Antineoplastic treatment\n* Date of consent no later than 2 weeks after start of first-line treatment\n\nExclusion Criteria:\n\n* No pancreatic cancer\n* Below 18 years and older\n* No antineoplastic treatment\n* Date of consent later than 2 weeks after start of first-line treatment'}, 'identificationModule': {'nctId': 'NCT02089269', 'acronym': 'AMETHYST', 'briefTitle': 'Tumor Registry Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'iOMEDICO AG'}, 'officialTitle': 'Clinical Registry on Treatment Reality and Sequential Treatments of Patients with Resectable or Locally Advanced/metastatic Pancreatic Cancer in Real-life Practice in Germany', 'orgStudyIdInfo': {'id': 'iOM-01281'}, 'secondaryIdInfos': [{'id': 'Tumorregister Pankreaskarzinom', 'type': 'OTHER', 'domain': 'iOMEDICO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': '2,200 patients with unresectable locally advanced or metastatic pancreatic cancer, treated in palliative intention'}, {'label': 'Cohort 2', 'description': '125 patients with localized, resectable pancreatic cancer treated in neo-adjuvant or adjuvant intention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'iOMEDICO', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Susanna Hegewisch-Becker, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Outpatient Clinic, Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}