[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100209193":3},{"organization":4,"armGroups":7,"interventions":48,"overallOfficials":68,"centralContacts":72,"locations":77,"responsibleParty":242,"collaborators":244,"id":252,"slug":253,"hasResults":254,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":254,"sex":259,"minAge":260,"maxAge":67,"enrollmentInfo":261,"targetDuration":67,"studyType":264,"phases":265,"briefSummary":267,"conditions":268,"keywords":274,"overallStatus":80,"whyStopped":67,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,16,20,24,28,32,36,40,44],{"label":9,"type":10,"description":11,"interventionNames":12},"Familial pancreas cancer relatives","ACTIVE_COMPARATOR","High Risk Group 2 (familial pancreatic cancer relatives):\n\n1. \\> 55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and\n2. come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and\n3. have a first-degree relationship with at least one of the relatives with pancreatic cancer.\n\nIf there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened",[13,14,15],"Drug: Secretin","Diagnostic Test: MRI","Other: Tumor marker gene test with CA19-9",{"label":17,"type":10,"description":18,"interventionNames":19},"Group 1 germline mutation carrier","High Risk Group 3 (Group 1 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \\~10% or higher):\n\na. \\> 50 years old or 10 years younger than the age of the youngest relative affected, if pancreatic cancer is in family, and b. The Patient is a carrier of a confirmed BRCA2, ATM or PALB2 mutation, regardless of family history of pancreatic cancer. b.\\> Individual is a carrier of a confirmed FAMMM (p16\u002FCDKN2A) mutation, age 40 years or older, regardless of family history of pancreas cancer.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Group 2 germline mutation carrier","High Risk Group 4 (Group 2 germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \\~5%):\n\n1. \\> 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and\n2. The patient is a carrier of a confirmed BRCA1 or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation, and there is \\> 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Hereditary pancreatitis","High risk group 5 (hereditary pancreatitis) with confirmed gene mutations that predispose to chronic pancreatitis, such as PRSS1, PRSS2, CTRC) and age 50 years or older (these patients have an estimated lifetime risk for pancreatic cancer of 40%) or twenty-years since their first attack of pancreatitis, whichever age is younger.",[13,14,15],{"label":29,"type":10,"description":30,"interventionNames":31},"Peutz-Jeghers Syndrome","1. At least 30 years old, and\n2. at least 2 of 3 criteria diagnostic of Peutz-Jeghers syndrome (characteristic intestinal hamartomatous polyps, mucocutaneous melanin deposition, or family history of Peutz-Jeghers syndrome), or,\n3. known STK11 gene mutation carrier",[13,14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"Negative control","1. are undergoing routine EGD or Colonoscopy; or Endoscopic Ultrasound (EUS) and\u002For Endoscopic Retrograde Cholangiopancreatography (ERCP) for non-pancreatic indications as part of their standard medical care, and\n2. have no clinical or radiologic suspicion of pancreatic disease (chronic pancreatitis or pancreatic cancer)",[13],{"label":37,"type":10,"description":38,"interventionNames":39},"Chronic Pancreatitis","1. are undergoing EUS and\u002For ERCP for evaluation and\u002For treatment of suspected or proven chronic pancreatitis as part of their standard medical care, and,\n2. have no clinical or radiologic suspicion of pancreatic cancer",[13],{"label":41,"type":10,"description":42,"interventionNames":43},"Pancreas cancer","a. are undergoing EUS and\u002For ERCP for evaluation and\u002For treatment of suspected or proven pancreatic ductal adenocarcinoma (based on clinical and radiologic evidence)",[13],{"label":45,"type":10,"description":46,"interventionNames":47},"Pancreas cyst, IPMN evaluation","are undergoing EUS and\u002For ERCP for evaluation and\u002For treatment of suspected or proven pancreatic cancer precursor, intraductal papillary mucinous neoplasm (based on clinical presentation and radiologic or prior EUS or radiologic evidence of a dilated main pancreatic duct and\u002For pancreatic cystic lesion communicating with the pancreatic ductal system).",[13],[49,56,63],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Secretin","inject Secretin to stimulate pancreatic digestive fluid, which is collected in duodenum near ampulla via endoscope suction port. This fluid will be assessed for biomarkers.",[37,9,17,21,25,33,41,45,29],[55],"ChiRhoStim",{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"DIAGNOSTIC_TEST","MRI","MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.",[9,17,21,25,29],[62],"MRCP",{"type":6,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Tumor marker gene test with CA19-9","A tumor marker gene test that will be used to stratify individuals into one of several circulating tumor marker reference ranges for CA19-9. The variants in the genes FUT3 and FUT2 affect the levels of CA19-9.",[9,17,21,25,29],null,[69],{"name":70,"affiliation":5,"role":71},"Michael Goggins, MD","PRINCIPAL_INVESTIGATOR",[73],{"name":74,"role":75,"phone":67,"phoneExt":67,"email":76},"Hilary Cosby, RN","CONTACT","hcosby1@jhmi.edu",[78,99,117,139,156,171,183,204,224],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Yale University","RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-72.92816,41.30815,{"lat":90,"lon":89},[93,97],{"name":94,"role":75,"phone":95,"phoneExt":67,"email":96},"Scott Merenda, BSN","203-785-7019","scott.merenda@yale.edu",{"name":98,"role":71,"phone":67,"phoneExt":67,"email":67},"James Farrell, MD",{"facility":100,"status":80,"city":101,"state":102,"zip":103,"country":84,"countryCode":85,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Johns Hopkins Hospital","Baltimore","Maryland","21287",{"type":87,"coordinates":105},[106,107],-76.61219,39.29038,{"lat":107,"lon":106},[110,113,114],{"name":111,"role":75,"phone":112,"phoneExt":67,"email":76},"Hilary Cosby, RN, CGRN","410-502-2893",{"name":70,"role":71,"phone":67,"phoneExt":67,"email":67},{"name":115,"role":116,"phone":67,"phoneExt":67,"email":67},"Marcia I Canto, MD","SUB_INVESTIGATOR",{"facility":118,"status":80,"city":119,"state":120,"zip":121,"country":84,"countryCode":85,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Dana Farber Cancer Center, Harvard University","Boston","Massachusetts","02215",{"type":87,"coordinates":123},[124,125],-71.05977,42.35843,{"lat":125,"lon":124},[128,132,135,137],{"name":129,"role":75,"phone":130,"phoneExt":67,"email":131},"Samantha Kuney","617-632-4788","Samantha_Kuney@dfci.harvard.edu",{"name":133,"role":75,"phone":67,"phoneExt":67,"email":134},"Ethan Provost","ethan_provost@dfci.harvard.edu",{"name":136,"role":71,"phone":67,"phoneExt":67,"email":67},"Sapna Syngal, MD",{"name":138,"role":116,"phone":67,"phoneExt":67,"email":67},"Matthew Yurgelun, MD",{"facility":140,"status":80,"city":141,"state":142,"zip":143,"country":84,"countryCode":85,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"University of Michigan","Ann Arbor","Michigan","48109",{"type":87,"coordinates":145},[146,147],-83.74088,42.27756,{"lat":147,"lon":146},[150,154],{"name":151,"role":75,"phone":152,"phoneExt":67,"email":153},"Sarah Volk","734-998-1274","stomanic@med.umich.edu",{"name":155,"role":116,"phone":67,"phoneExt":67,"email":67},"Elena Stoffel, MD",{"facility":157,"status":80,"city":158,"state":158,"zip":159,"country":84,"countryCode":85,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"NYU Langone Medical Center","New York","10016",{"type":87,"coordinates":161},[162,163],-74.00597,40.71427,{"lat":163,"lon":162},[166,169],{"name":167,"role":75,"phone":67,"phoneExt":67,"email":168},"Emil Agarunov","emil.agarunov@nyulangone.org",{"name":170,"role":71,"phone":67,"phoneExt":67,"email":67},"Tamas Gonda, MD",{"facility":172,"status":80,"city":158,"state":158,"zip":173,"country":84,"countryCode":85,"cosmosGeoPoint":174,"geoPoint":176,"contacts":177},"Columbia University Medical Center","10032",{"type":87,"coordinates":175},[162,163],{"lat":163,"lon":162},[178,181],{"name":179,"role":75,"phone":67,"phoneExt":67,"email":180},"Katharine Godfrey","kb3217@cumc.columbia.edu",{"name":182,"role":71,"phone":67,"phoneExt":67,"email":67},"Fay Kastrinos, MD",{"facility":184,"status":80,"city":185,"state":186,"zip":187,"country":84,"countryCode":85,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Case Comprehensive Cancer Center, Case Western Medical Reserve","Cleveland","Ohio","44106",{"type":87,"coordinates":189},[190,191],-81.69541,41.4995,{"lat":191,"lon":190},[194,198,202],{"name":195,"role":75,"phone":196,"phoneExt":67,"email":197},"Barbara Heaton","216-844-7314","Barbara.Heaton@UHhospitals.org",{"name":199,"role":75,"phone":200,"phoneExt":67,"email":201},"Wendy Brock, RN","216-844-3853","wendy.Brock@UHhospitals.org",{"name":203,"role":116,"phone":67,"phoneExt":67,"email":67},"Amitabh Chak, MD",{"facility":205,"status":80,"city":206,"state":207,"zip":208,"country":84,"countryCode":85,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":87,"coordinates":210},[211,212],-75.16362,39.95238,{"lat":212,"lon":211},[215,219,222],{"name":216,"role":75,"phone":217,"phoneExt":67,"email":218},"Daniel Clay","215-360-0905","Daniel.Clay@Pennmedicine.upenn.edu",{"name":220,"role":75,"phone":67,"phoneExt":67,"email":221},"Sara Karley","sara.karley@pennmedicine.upenn.edu",{"name":223,"role":116,"phone":67,"phoneExt":67,"email":67},"Bryson Katona, MD",{"facility":225,"status":80,"city":226,"state":207,"zip":227,"country":84,"countryCode":85,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"University of Pittsburgh","Pittsburgh","15213",{"type":87,"coordinates":229},[230,231],-79.99589,40.44062,{"lat":231,"lon":230},[234,237,240],{"name":235,"role":75,"phone":67,"phoneExt":67,"email":236},"Christine Decapite","decapitec@upmc.edu",{"name":238,"role":75,"phone":67,"phoneExt":67,"email":239},"Sara Booz","boozs@upmc.edu",{"name":241,"role":71,"phone":67,"phoneExt":67,"email":67},"Randall Brand, MD",{"type":243,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR",[245,248,250],{"name":246,"class":247},"National Cancer Institute (NCI)","NIH",{"name":249,"class":247},"National Institutes of Health (NIH)",{"name":251,"class":6},"American Association for Cancer Research","100209193","phase-3-the-cancer-of-the-pancreas-screening-5-caps5study-100209193",false,"NCT02000089","The Cancer of the Pancreas Screening-5 CAPS5)Study","CAPS5","Inclusion Criteria:\n\n* Hereditary Pancreatitis or\n* Peutz-Jeghers Syndrome or\n* Strong family history of pancreas cancer on one side of the family tree or\n* Confirmed germline mutation carrier (BRCA2, FAMMM (CDKN2A\u002Fp16), PALB2, BRCA1, ATM, HNPCC, Lynch Syndrome (hMLH1, hMSH2, PMS2, hMSH6, EpCAM) PRSS1, PRSS2, R122H, N291l, SPINK1, CFTR\n* Endoscopic evaluation of pancreas scheduled\n\nExclusion Criteria:\n\n* Medical comorbidities or coagulopathy that contraindicate endoscopy\n* Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis\n* Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope\n* Poor performance status\n* Inability to provide informed consent\n* Pregnancy.","ALL","18 Years",{"count":262,"type":263},9000,"ESTIMATED","INTERVENTIONAL",[266],"PHASE3","Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.",[269,270,271,272,273],"Pancreas Cancer","Peutz-Jeghers Syndrome (PJS)","Gene Mutation","Germline Mutation Carrier","Lynch Syndrome",[275,276,277,278,279,280,281,282,273,283,284,285,286],"familial pancreas cancer","(Peutz-Jeghers Syndrome) PJS","Breast cancer (BRCA) 2","Partner and Locator of BRCA2 (PALB2)","Familial Atypical Multiple Mole- Melanoma (FAMMM)","p16, CDKN2A","Breast Cancer (BRCA)1","(hereditary non-polyposis colorectal cancer or Lynch syndrome) HNPCC","hereditary pancreatitis","Protease Serine (PRSS)","Chymotrypsin C (CTRC)","Ataxia Telangiectasia Mutated(ATM)","2025-10-08",{"date":289,"type":290},"2025-10-09","ACTUAL",{"date":292,"type":290},"2014-01-06",{"date":294,"type":263},"2029-06",{"name":5,"class":6},9]