Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-25 @ 10:30 PM
Study NCT ID:
NCT05248750
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2022-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-02-10', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free-survival (PFS)', 'timeFrame': 'From date of enrollment assessed until death or up to 2 years', 'description': 'To assess the impact of comprehensive genetic, stromal, and immunological factors on PFS defined as the time from the date of trial entry until disease progression or relapse.'}, {'measure': 'Overall survival', 'timeFrame': 'From date of enrollment assessed until death or up to 2 years', 'description': 'To assess the impact of comprehensive genetic, stromal, and immunological factors on Overall survival defined as the length of time (in days) between the treatment date and the date of death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'endoscopic ultrasound (EUS)', 'personalized medicine'], 'conditions': ['Pancreas Cancer']}, 'descriptionModule': {'briefSummary': "Pancreatic ductal adenocarcinoma (PDAC) complexity, where genetic, stromal, and immunological factors all interact with each other, is responsible for the overall poor response of PDAC to chemotherapeutic agents, making this a lethal disease. The investigators hypothesize that: (i) dissection of genetic, stromal, and immunological factors on endoscopic ultrasound fine needle biopsy (EUS-FNB) tissue samples from unresectable PDAC patients' will allow to determine prognostic factors in this patient population; (ii) treatment response and acquisition of tumor chemotherapy resistance could be related to genetic heterogeneity between the primary and metastatic sites and alteration of the molecular profile under drug' selection pressure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study concerns consecutive individuals with a solid pancreatic lesion who will undergo diagnostic EUS-FNB over a 3 year period. Those with a histological diagnosis of PDAC will be enrolled in the study. Enrollment will include patients with unresectable disease, which can be divided in different stages, i.e. borderline resectable, locally advanced, and metastatic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to EUS with FNB for suspected pancreatic cancer unresectable or metastatic based on imaging findings\n* Availability of biopsies obtained during EUS-FNB\n* Histological diagnosis of pancreatic ductal adenocarcinoma of any stage\n* Patients must be fit for chemotherapy administration\n* They have to express their willingness to be followed up at our pancreatic high volume centers\n* Age \\>18 and \\<80 years\n* Able to sign informed consent\n\nExclusion Criteria:\n\n* Histological diagnoses other than pancreatic ductal adenocarcinoma\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT05248750', 'briefTitle': 'Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'Genetic, Microenvironmental, and Immunological Factors in Unresectable Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'PDAC AIRC'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Guido Costamagna, MD, Prof.', 'role': 'CONTACT', 'email': 'gcostamagna@rm.unicatt.it', 'phone': '+39.0630156580'}, {'name': 'MD', 'role': 'CONTACT'}], 'facility': '"Agostino Gemelli" Hospital, Catholic University of Sacred Heart', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Alberto Larghi, MD', 'role': 'CONTACT', 'email': 'alberto.larghi@yahoo.it', 'phone': '+390630156580'}, {'name': 'Carolina Gualtieri', 'role': 'CONTACT', 'phone': '+390630156580'}], 'overallOfficials': [{'name': 'Alberto Larghi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guido Costamagna', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}