Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-04 @ 8:16 AM
Study NCT ID:
NCT03266757
Status:
COMPLETED
Last Update Posted:
2019-04-05
First Post:
2017-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical practice-treatments', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'progression Free Survival', 'timeFrame': '2 years'}, {'measure': 'Overall Survival', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Observational study of the Clinical Practice in patients with Borderline resectable or resectable or advanced pancreatic adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Public and Private Hospital Institutions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients Age 18 or older with histologically confirmed ductal pancreatic adenocarcinoma as a primary tumor\n* Patients with ductal pancreatic adenocarcinoma (Borderline resectable or resectable or advanced)\n* Patients that are alive and under treatment or follow up\n* Signed informed consent (ICF)\n\nExclusion Criteria:\n\n* Presence of other primary tumors\n* Pancreatic adenocarcinoma due to metastasis from other primary tumor(s)\n* Neuroendocrine or other pancreatic carcinoma other than ductal adenocarcinoma\n* Patients who refuse to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03266757', 'briefTitle': 'Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Society of Medical Oncology'}, 'officialTitle': 'Observational Study of the Clinical Practice in Patients With Borderline Resectable or Resectable or Advanced Pancreatic Adenocarcinoma in Greece', 'orgStudyIdInfo': {'id': 'N/A-NI-PANC-HeSMO-005490'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Society of Medical Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}