Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-02 @ 6:23 AM
Study NCT ID:
NCT05043532
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2021-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient undergoing the procedure, research coordinator calling patients for follow-up and the pathologist performing molecular profiling will be blinded to the randomization group.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-09-07', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy', 'timeFrame': '7 days', 'description': 'Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy of pancreatic adenocarcinoma, with comparison between two and three passes during fine needle biopsy'}], 'secondaryOutcomes': [{'measure': 'Number of actionable mutations detected on molecular profiling', 'timeFrame': '7 days', 'description': 'Number of actionable mutations detected on molecular profiling'}, {'measure': 'Rate of technical success', 'timeFrame': '1 day', 'description': 'Rate of technical success of EUS-guided fine needle biopsy. Technical success is defined as the successful completion of the EUS-guided fine needle biopsy procedure.'}, {'measure': 'Rate of procedure-related adverse events', 'timeFrame': '7 days', 'description': 'Rate of procedure-related adverse events, defined as any adverse event occurring as a result of EUS-guided fine needle biopsy'}, {'measure': 'Type of actionable mutations detected on molecular profiling', 'timeFrame': '7 days', 'description': 'Type of actionable mutations detected on molecular profiling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Pancreatic Neoplasms', 'Adenocarcinoma of the Pancreas']}, 'descriptionModule': {'briefSummary': 'This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer', 'detailedDescription': 'Endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. By using novel fine needle biopsy (FNB) needles during EUS-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of \\>90%.\n\nMolecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. As the procurement of core tissue is possible with EUS-FNB, adequate tissue can now be obtained for molecular profiling. However, the number of passes required during EUS-FNB to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice.\n\nThe primary aim of this study is therefore to elucidate the optimal number of passes required during EUS-FNB to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years and over\n2. Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Females who are pregnant\n3. Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound\n4. Biopsied pancreatic mass is not adenocarcinoma on pathology'}, 'identificationModule': {'nctId': 'NCT05043532', 'briefTitle': 'Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Orlando Health, Inc.'}, 'officialTitle': 'Randomized Trial to Evaluate the Optimal Number of Passes Required for Molecular Profiling During Endoscopic Ultrasound-guided Fine Needle Biopsy of Pancreatic Adenocarcinoma', 'orgStudyIdInfo': {'id': '21.069.05'}, 'secondaryIdInfos': [{'id': '1741103', 'type': 'OTHER', 'domain': 'Orlando Health IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Two passes performed during EUS-FNB of pancreatic adenocarcinoma', 'description': 'Once the pancreatic mass is identified on endoscopic ultrasound examination, total of two passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.', 'interventionNames': ['Procedure: 2 passes during EUS-guided fine needle biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Three passes performed during EUS-FNB of pancreatic adenocarcinoma', 'description': 'Once the pancreatic mass is identified on endoscopic ultrasound examination, total of three passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.', 'interventionNames': ['Procedure: 3 passes during EUS-guided fine needle biopsy']}], 'interventions': [{'name': '2 passes during EUS-guided fine needle biopsy', 'type': 'PROCEDURE', 'description': 'Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of two passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.', 'armGroupLabels': ['Two passes performed during EUS-FNB of pancreatic adenocarcinoma']}, {'name': '3 passes during EUS-guided fine needle biopsy', 'type': 'PROCEDURE', 'description': 'Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of three passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.', 'armGroupLabels': ['Three passes performed during EUS-FNB of pancreatic adenocarcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Ji Young Bang, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orlando Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orlando Health, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}