Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-26 @ 10:51 PM
Study NCT ID:
NCT03140592
Status:
UNKNOWN
Last Update Posted:
2021-03-19
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Cancer Models Developed From EUS Guided Biopsy Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010181', 'term': 'Pancreatic Cyst'}], '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': 'D003560', 'term': 'Cysts'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'biopsies of your pancreatic mass'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful generation of pancreatic organoids', 'timeFrame': '6 years', 'description': 'The two extra biopsy tissues collected for only research purposes will be used to generate pancreatic organoids in a in-vivo as well as in-vitro setting.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Pancreatic Adenocarcinoma', 'Pancreatic Cyst']}, 'referencesModule': {'references': [{'pmid': '32119924', 'type': 'DERIVED', 'citation': "Lacomb JF, Plenker D, Tiriac H, Bucobo JC, D'souza LS, Khokhar AS, Patel H, Channer B, Joseph D, Wu M, Tuveson DA, Li E, Buscaglia JM. Single-Pass vs 2-Pass Endoscopic Ultrasound-Guided Fine-Needle Biopsy Sample Collection for Creation of Pancreatic Adenocarcinoma Organoids. Clin Gastroenterol Hepatol. 2021 Apr;19(4):845-847. doi: 10.1016/j.cgh.2020.02.045. Epub 2020 Feb 29."}, {'pmid': '29325707', 'type': 'DERIVED', 'citation': 'Tiriac H, Bucobo JC, Tzimas D, Grewel S, Lacomb JF, Rowehl LM, Nagula S, Wu M, Kim J, Sasson A, Vignesh S, Martello L, Munoz-Sagastibelza M, Somma J, Tuveson DA, Li E, Buscaglia JM. Successful creation of pancreatic cancer organoids by means of EUS-guided fine-needle biopsy sampling for personalized cancer treatment. Gastrointest Endosc. 2018 Jun;87(6):1474-1480. doi: 10.1016/j.gie.2017.12.032. Epub 2018 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'Pancreatic cancer is a very aggressive cancer. Over the past 40 years there has not been much progress made in reducing deaths from this cancer. Recently, new models of pancreatic cancers have been generated from mouse and human tissues. These models have used larger pieces of tissues taken from surgical removal of pancreatic cancers.\n\nThe purpose of this study is to determine whether these new pancreatic cancer models can be generated from the small biopsies we take to make the diagnosis of the pancreatic mass.', 'detailedDescription': 'The Endoscopic Ultrasound guided pancreatic biopsy tissue collected for only research purposes will be used to generate organoids in a in-vivo and in-vitro setting.\n\nThe development of these methods may help scientists identify new treatments for pancreatic cancer and to potentially develop more personalized approaches to treating pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are scheduled for an EUS-FNB performed by a member of the Stony Brook Interventional Endoscopy Section of the Division of Gastroenterology and Hepatology', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Patients who are scheduled for an EUS-FNB of pancreatic mass(es) suspicious for pancreatic ductal adenocarcinoma performed by a member of the Stony Brook Interventional Endoscopy Section of the Division of Gastroenterology and Hepatology\n\n1. Age ≥ 18 years\n2. Literate and able/willing to provide informed consent for participation in research.\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Not literate or unable/unwilling to provide informed consent for EUS-FNB research biopsies\n3. Pregnancy as determined by serum or urine HCG test performed as standard of clinical care for all women of childbearing age and documented on subjects' electronic medical record"}, 'identificationModule': {'nctId': 'NCT03140592', 'briefTitle': 'Pancreatic Cancer Models Developed From EUS Guided Biopsy Tissue', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'EUS-guided Biopsy of Pancreatic Mass Lesions for Developing Patient -Derived Cancer Models', 'orgStudyIdInfo': {'id': 'IRBNet # 618834'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'Two extra EUS guided pancreatic biopsies collected for only research purposes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Buscaglia, MD', 'role': 'CONTACT', 'email': 'jonathan.buscaglia@stonybrookmedicine.edu'}], 'facility': 'Stony Brook University', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'centralContacts': [{'name': 'Jonathan Buscaglia, MD', 'role': 'CONTACT', 'email': 'jonathan.buscaglia@stonybrookmedicine.edu', 'phone': '6314447225'}, {'name': 'Joseph LaComb, BS', 'role': 'CONTACT', 'email': 'joseph.lacomb@stonybrookmedicine.edu', 'phone': '6314449532'}], 'overallOfficials': [{'name': 'Jonathan Buscaglia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jonathan Buscaglia', 'investigatorAffiliation': 'Stony Brook University'}}}}