Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
Study NCT ID:
NCT04380766
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2020-04-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Covid-19 Pandemic and Pancreatic Surgery in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-02-04', 'releaseDate': '2021-02-02'}, {'resetDate': '2021-04-27', 'releaseDate': '2021-04-22'}], 'estimatedResultsFirstSubmitDate': '2021-02-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D000086382', 'term': 'COVID-19'}], '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'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 730}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in pancreatic cancer management during the COVID-19 pandemic', 'timeFrame': 'From admission to discharge/last outpatient visit, whichever comes first, assessed up to the 30th of June 2020'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic cancer', 'Pancreatic surgery', 'COVID-19'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '34817837', 'type': 'DERIVED', 'citation': 'Quero G, Pecorelli N, Paiella S, Fiorillo C, Petrone MC, Rosa F, Capretti G, Laterza V, Kauffmann E, Nobile S, Butturini G, Ferrari G, Coratti A, Casadei R, Mazzaferro V, Boggi U, Zerbi A, Salvia R, Falconi M, Alfieri S. Quantitative assessment of the impact of COVID-19 pandemic on pancreatic surgery: an Italian multicenter analysis of 1423 cases from 10 tertiary referral centers. Updates Surg. 2022 Feb;74(1):255-266. doi: 10.1007/s13304-021-01171-8. Epub 2021 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with diagnosis of pancreatic cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nall patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods\n\nExclusion Criteria:\n\n* patients under the age of 18\n* inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04380766', 'acronym': 'PanCOVID', 'briefTitle': 'Covid-19 Pandemic and Pancreatic Surgery in Italy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Effects of Covid-19 Pandemic on Pancreatic Surgery in Italy. A Multicenter Observational Clinical Study', 'orgStudyIdInfo': {'id': 'FPGemelliIRCCS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-COVID', 'description': 'All patients with pancreatic cancer diagnosis before COVID-19 pandemic', 'interventionNames': ['Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer']}, {'label': 'COVID', 'description': 'All patients with pancreatic cancer diagnosis during COVID-19 pandemic', 'interventionNames': ['Procedure: Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer']}], 'interventions': [{'name': 'Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer', 'type': 'PROCEDURE', 'description': 'Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes', 'armGroupLabels': ['COVID', 'Pre-COVID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sergio Alfieri', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-02-02', 'type': 'RELEASE'}, {'date': '2021-02-04', 'type': 'RESET'}, {'date': '2021-04-22', 'type': 'RELEASE'}, {'date': '2021-04-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'ALFIERI SERGIO, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}