Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-06 @ 1:35 PM
Study NCT ID:
NCT04099134
Status:
RECRUITING
Last Update Posted:
2019-09-25
First Post:
2019-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Tumor tissue from biopsies or surgery\n* Blood samples at defined timepoints'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General assessment of applied therapy modalities in pancreatic cancer', 'timeFrame': 'First diagnose to death or end of surveillance (5 years after curative resection)'}, {'measure': 'Quality of life in pancreatic cancer patients', 'timeFrame': 'First diagnose to death or end of surveillance (5 years after curative resection)', 'description': 'EORTC QLQ c30 and PAN 26'}], 'secondaryOutcomes': [{'measure': 'General epidemiologic assessment', 'timeFrame': 'First diagnose to death or end of surveillance (5 years after curative resection)', 'description': 'Epidemiologic questionaire'}, {'measure': 'Assessment of tumor surveillance in pancreatic cancer patients', 'timeFrame': 'First diagnose to death or end of surveillance (5 years after curative resection)'}, {'measure': 'Evaluation of predictive and prognostic markers', 'timeFrame': 'First diagnose to death or end of surveillance (5 years after curative resection)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreas Adenocarcinoma', 'Pancreas Cancer']}, 'descriptionModule': {'briefSummary': 'PaCaReg is a multicenter registry trial aiming in the assessement of clinical, epidemiological and biological profiles in patients with pancreatic ductal adenocarcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult newly diagnosed patients with a PDAC could be included in the registry trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment naive histologically or cytologically proven pancreatic ductal adenocarcinoma (PDAC) or highly suspicious diagnosis (only pre-curative-intended resection)\n* Age =\\>18 years\n* written informed consent\n\nExclusion Criteria:\n\n* papillary cancer\n* neuroendocrine pancreatic tumors'}, 'identificationModule': {'nctId': 'NCT04099134', 'acronym': 'PaCaReg', 'briefTitle': 'PACAREG: a Multicenter Registry Trial in Pancreatic Ductal Adencarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'PaCaReg: A Multicenter Registry Trial for the Assessement of Clinical, Epidemiological and Biological Profiles in Patients With Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'PaCaReg'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ulm', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Seufferlein, MD', 'role': 'CONTACT', 'email': 'thomas.seufferlein@uniklinik-ulm.de', 'phone': '0049-731-500-44501'}], 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Thomas Seufferlein, MD', 'role': 'CONTACT', 'email': 'thomas.seufferlein@uniklinik-ulm.de', 'phone': '+49 731 50044501'}], 'overallOfficials': [{'name': 'Thomas Seufferlein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ulm University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department for internal medicine I', 'investigatorFullName': 'Thomas Seufferlein', 'investigatorAffiliation': 'University of Ulm'}}}}