[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525527":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":41,"centralContacts":45,"locations":50,"responsibleParty":78,"collaborators":22,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":22,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":22,"enrollmentInfo":90,"targetDuration":22,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":70,"whyStopped":22,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Dana-Farber Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pancreatic Cancer High-Risk Participants","EXPERIMENTAL","Study procedures will be conducted as follows:\n\n* Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI\u002FMRCP).\n* Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)\u002FMagnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months.\n* Blood tests and questionnaires every 6 months.\n* Follow up visits.",[13,14,15,16],"Other: Screening Blood Tests","Diagnostic Test: Endoscopic Ultrasound","Combination Product: Magnetic Resonance Imaging","Combination Product: Magnetic Resonance Cholangiopancreatography",[18,23,30,36],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"Screening Blood Tests","Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","Endoscopic Ultrasound","Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.",[9],[29],"EUS",{"type":31,"name":32,"description":26,"armGroupLabels":33,"otherNames":34},"COMBINATION_PRODUCT","Magnetic Resonance Imaging",[9],[35],"MRI",{"type":31,"name":37,"description":26,"armGroupLabels":38,"otherNames":39},"Magnetic Resonance Cholangiopancreatography",[9],[40],"MRCP",[42],{"name":43,"affiliation":5,"role":44},"Matthew Yurgelun, MD","PRINCIPAL_INVESTIGATOR",[46],{"name":43,"role":47,"phone":48,"phoneExt":22,"email":49},"CONTACT","617-582-8673","matthew_yurgelun@dfci.harvard.edu",[51,68],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Brigham and Women's Hospital","NOT_YET_RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-71.05977,42.35843,{"lat":63,"lon":62},[66,67],{"name":43,"role":47,"phone":48,"phoneExt":22,"email":49},{"name":43,"role":44,"phone":22,"phoneExt":22,"email":22},{"facility":69,"status":70,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Dana Farber Cancer Institute","RECRUITING",{"type":60,"coordinates":72},[62,63],{"lat":63,"lon":62},[75,76],{"name":43,"role":47,"phone":48,"phoneExt":22,"email":49},{"name":77,"role":44,"phone":22,"phoneExt":22,"email":22},"Matthew B Yurgelun, MD",{"type":44,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Matthew B. Yurgelun, MD","Principal Investigator","100525527","early-phase-1-prospective-screening-for-pancreatic-ductal-adenocarcinoma-in-high-risk-individuals-100525527",false,"NCT06122896","Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals","Inclusion Criteria:\n\nParticipants must meet any of the following:\n\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in STK11, and age ≥30 years.\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND\n\n  • Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic\u002Flikely pathogenic germline variant.\n* Individuals with pathogenic\u002Flikely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).\n* Individuals with familial pancreatic cancer including:\n\n  * Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant, OR\n  * Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant, OR\n  * Family history of exocrine pancreatic cancer in ≥3 first- and\u002For second-degree relatives from the same side of the family, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant.\n* Individuals who are undergoing clinically recommended pancreatic cancer surveillance.\n\nExclusion Criteria:\n\n* Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.\n* Individuals with any active metastatic cancer.\n* Individuals who are unable to give informed consent.\n* Individuals who are under the age of 18 (infants, children, teenagers).\n* Individuals unable to tolerate Magnetic Resonance Imaging\u002FMagnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.\n* Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.",true,"ALL","18 Years",{"count":91,"type":92},5000,"ESTIMATED","INTERVENTIONAL",[95],"EARLY_PHASE1","The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.",[98,99,100,101,102],"Pancreatic Cancer","Pancreatic Ductal Adenocarcinoma","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Neoplasm",[98,99,100,101,102],"2026-05-27",{"date":106,"type":107},"2026-05-29","ACTUAL",{"date":109,"type":107},"2023-11-21",{"date":111,"type":92},"2041-10-31",{"name":5,"class":6},2]