Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT04291651
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2020-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
UCSF PANC Cyst Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D000077779', 'term': 'Pancreatic Intraductal Neoplasms'}, {'id': 'D009078', 'term': 'Mucocele'}, {'id': 'D018293', 'term': 'Cystadenoma, Serous'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D003537', 'term': 'Cystadenoma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Patients in this study will have the option of donating blood for biobanking, approximately 10cc of plasma and 10cc of serum. Patients will also have the opportunity to donate a saliva sample at the time of study registration, or at a later date.\n\nFurther, samples that are routinely collected for diagnostic purposes may be collected and banked at the time of their clinically routine procedure. If a patient consents to the use of extra material for research purposes, the biological samples will be banked and the blood, and/or pancreatic juice/cystic fluid, tissues, and saliva will be used for identification and characterization of potential biomarkers from de-identified samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer', 'timeFrame': '1-10 years', 'description': 'While not the primary outcome measure, the development of cancer from a pancreatic cyst is a critically important study endpoint, which the investigators do not expect to be frequent occurrence.'}, {'measure': 'Indolency', 'timeFrame': '1-10 years', 'description': 'If a patient with a pancreatic cyst experiences no or minimal change in size, and no development of worrisome or high-risk stigmata (Tanaka 2017), this will be considered to be an indolent lesion. Most patients will fall under this category.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cyst', 'Pancreatic Cystic Lesion', 'Pancreatic Cancer', 'Intraductal Papillary Mucinous Neoplasm', 'Serous Cystadenoma', 'Mucinous Cystic Neoplasm', 'Cancer Epidemiology', 'Early Detection Research'], 'conditions': ['Pancreatic Cyst', 'Pancreatic Neoplasms', 'Pancreatic Cancer', 'Pancreatic Diseases', 'Pancreatic Intraductal Papillary Mucinous Neoplasm', 'Intraductal Papillary Mucinous Neoplasm', 'Pancreatic Ductal Adenocarcinoma', 'Mucinous Cyst']}, 'descriptionModule': {'briefSummary': 'Pancreatic cysts are found incidentally on 15-50% of CT and MRIs for all indications and their prevalence is increasing. Many of these cysts may be precursors to pancreatic cancer, and thus pose a substantial risk, however, the vast majority are benign. Increased detection of pancreatic cysts provides an opportunity to diagnose pancreatic malignancy at an early, curable stage yet also increases the potential to over-treat clinically insignificant lesions. This presents a clinical challenge to prevent unnecessary resection of indolent disease, with associated risks of infections, bleeding, diabetes, and costly disability. Unfortunately, there is little information on the epidemiology and natural history of pancreatic cysts to help guide management.', 'detailedDescription': 'This study develops a large, prospectively managed, electronic, patient-directed pancreatic cyst registry based at UCSF. The UCSF Pancreatic Cystic Lesions Registry (PANC Cyst) will facilitate work to improve clinical care and understanding of pancreatic cysts by prospective follow-up of patients with cystic lesions, especially the diagnostically challenging small cysts, to identify factors related to cyst formation and progression to malignancy. Longitudinal data capture that includes clinical outcomes will also enable us to more precisely define anatomic, radiographic and biomarker information that can be used to differentiate populations of patients for whom surgery is indicated, surveillance is warranted, or no further evaluation is necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The majority of patients in this study will be over the age of 60 years old, due to the natural age distribution of pancreatic cysts. There will be an approximately even distribution of males and females.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The inclusion criteria for this study are intentionally broad. Eligible patients for prospective enrollment will include\n* Adults ≥ 30 years of age\n* Have a radiographic or endoscopic diagnosis of at least one pancreatic cysts regardless of treatment status,\n* No history of pancreatic cancer,\n* Can speak and read English,\n* Have access to a computer or mobile device (\\~95% of U.S. population); and\n* Are able to complete an electronic informed consent.\n\nExclusion Criteria:\n\n* Patients who don't speak English,\n* Don't have access to a computer or mobile device; or\n* Patients who have a cancer diagnosis."}, 'identificationModule': {'nctId': 'NCT04291651', 'acronym': 'UCSF PCR', 'briefTitle': 'UCSF PANC Cyst Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Population-Based Analysis of Neoplastic Changes in Cystic Lesions of the Pancreas.', 'orgStudyIdInfo': {'id': '214521'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective', 'description': 'The registry will be populated with a retrospective cohort of patients previously identified as having pancreatic cysts.'}, {'label': 'Prospective', 'description': 'The prospectively enrolled patients in this study are the primary population of interest.', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'There are no study-specific interventions, as this is a prospective registry. However, patients will be asked to complete approximately 1-2 hours worth of surveys on things such as demographics, medical and surgical history, and pancreatic cyst-specific questionnaires.', 'armGroupLabels': ['Prospective']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charysa Santos, BS', 'role': 'CONTACT', 'email': 'Charysa.Santos@ucsf.edu', 'phone': '415-514-6914'}, {'name': 'M.D.', 'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu', 'phone': '877-827-3222'}, {'name': 'Kimberly Kirkwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paige M Bracci, PhD, MPH, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Charysa Santos, BS', 'role': 'CONTACT', 'email': 'Charysa.Santos@ucsf.edu', 'phone': '415-514-6914'}, {'name': 'Kimberly S Kirkwood, MD', 'role': 'CONTACT', 'email': 'kim.kirkwood@ucsf.edu', 'phone': '415-502-5577'}], 'overallOfficials': [{'name': 'Kimberly S Kirkwood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Paige M Bracci, PhD, MPH, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}