Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT03724435
Status:
TERMINATED
Last Update Posted:
2024-03-18
First Post:
2018-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry
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': 'ACTUAL', 'count': 21}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Competing trial will publish similar results', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-10-26', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain Related to Pancreatic Cancer', 'timeFrame': 'Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months', 'description': 'The proportion achieving a 2 point reduction or greater will be assessed at each time point and across time using the Brief Pain Inventory (Short Form). Pain will be rated from 0 (no pain) to 10 (pain as a bad as can imagine) .'}, {'measure': 'Performance Status', 'timeFrame': 'Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months', 'description': 'Improvement in performance status for a period of at least 4 consecutive weeks without showing any sustained worsening.'}, {'measure': 'Clinical Benefit Response (CBR)', 'timeFrame': 'Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months', 'description': 'The proportion of participants with a CBR will be measured at each follow-up time point.'}, {'measure': 'Impact on Quality of Life and Cost', 'timeFrame': 'Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months', 'description': 'Standardized instrument to measure of health-related quality of life.'}], 'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1 year', 'description': 'Time until the occurence of death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'focused ultrasound'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This pancreatic cancer registry aims to collect information on people around the world who select focused ultrasound (FUS) as part of their treatment for pancreatic cancer to learn about the performance of the focused ultrasound technology and health outcomes; the impact of focused ultrasound on your overall health; and provide an understanding of the current care for pancreatic cancer.', 'detailedDescription': 'The purpose of the registry is to collect data on the performance of the focused ultrasound (FUS) technology and health outcomes. A wide variety of approaches exist for using FUS on pancreatic cancer patients, and the primary goal is to capture this broad spectrum of approaches and their impact on patients overall health. This information will help provide a better understanding of current care, and may possibly direct further, more specific investigations that will follow this registry. After obtaining informed consent a baseline history, physical examination, laboratory studies, and imaging studies needed per standard of care will be performed. Patients\' treatment is determined by their caregivers only, and thus the registry will evaluate patient management in "real-world" conditions.\n\nEnrollment Goal: 100\n\nPrimary Outcomes: Pain related to pancreatic cancer, Objective response, Progression-free and overall survival, Performance Status, Clinical Benefit Response (CBR), Health-related quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The registry population will be drawn from patients who have been diagnosed with pancreatic cancer and are eligible for FUS therapy. Participants are allowed to receive standard-of-care treatment, including chemotherapy, radiation therapy, and best supportive care. Participants being treated in another FUS clinical trial may be included in this registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all registry procedures and availability for the duration of the registry\n* Histology proven pancreatic carcinoma in any area of pancreas\n* Pancreatic tumor that can be treated by FUS\n* Willingness and ability to complete follow-up interviews\n\nExclusion Criteria:\n\n* Any disease, condition or surgery which would result in a contraindication to undergoing FUS therapy.\n* Clinical trials of pancreatic cancer not of focused ultrasound or related activities\n* Other non-pancreatic cancer clinical trials'}, 'identificationModule': {'nctId': 'NCT03724435', 'acronym': 'ARRAY', 'briefTitle': 'Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry', 'organization': {'class': 'OTHER', 'fullName': 'Focused Ultrasound Foundation'}, 'officialTitle': 'ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY', 'orgStudyIdInfo': {'id': 'FUSREG001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pancreatic Cancer Participants', 'description': 'No intervention will be administered. Assessments are performed as standard of care.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Medical University of Pleven', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Headington', 'state': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospital', 'geoPoint': {'lat': 51.75737, 'lon': -1.21974}}], 'overallOfficials': [{'name': 'Joo Ha Hwang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Joan Vidal-Jove, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Mútua Terrassa'}, {'name': 'Tim Meakem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Focused Ultrasound Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Focused Ultrasound Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Navitas Clinical Research, Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}