[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02000089":3,"trial-entities:NCT02000089":269,"trial-summary:NCT02000089":291},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":40,"interventions":43,"primary_outcomes":71,"secondary_outcomes":76,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":14,"eligibility_criteria":83,"std_ages":98,"locations":101,"central_contacts":249,"overall_officials":252,"references":254,"see_also_links":268},"NCT02000089","NA_00087754","The Cancer of the Pancreas Screening-5 CAPS5)Study","RECRUITING","2029-06","2025-10","2025-10-09","2014-01-06","Johns Hopkins University","OTHER",false,"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.","The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.",[18,19,20,21,22],"Pancreas Cancer","Peutz-Jeghers Syndrome (PJS)","Gene Mutation","Germline Mutation Carrier","Lynch Syndrome",[24,25,26,27,28,29,30,31,22,32,33,34,35],"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)","INTERVENTIONAL","DIAGNOSTIC",[39],"PHASE3",{"count":41,"type":42},9000,"ESTIMATED",[44,60,67],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":58},"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.",[49,50,51,52,53,54,55,56,57],"Chronic Pancreatitis","Familial pancreas cancer relatives","Group 1 germline mutation carrier","Group 2 germline mutation carrier","Hereditary pancreatitis","Negative control","Pancreas cancer","Pancreas cyst, IPMN evaluation","Peutz-Jeghers Syndrome",[59],"ChiRhoStim",{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"DIAGNOSTIC_TEST","MRI","MRI abdomen with contrast (MRCP) will be clinically indicated for abnormal novel CA-19-9 lab results.",[50,51,52,53,57],[66],"MRCP",{"type":13,"name":68,"description":69,"armGroupLabels":70},"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.",[50,51,52,53,57],[72],{"measure":73,"description":74,"timeFrame":75},"Evaluate pancreatic juice for early cancer markers.","Aim #1: To evaluate pancreatic fluid mutations and circulating pancreatic epithelial cells as accurate markers of neoplasia by comparing their prevalence in cases with sporadic pancreatic neoplasia to healthy and disease controls.","10 years",[77],{"measure":78,"description":79,"timeFrame":75},"Compare pancreas juice with pancreas cyst fluid","Aim #2: To compare the prevalence of pancreatic fluid mutations and circulating pancreatic epithelial cells among a prospective cohort of individuals with sporadic pancreatic cysts undergoing pancreatic surveillance.","ALL","18 Years",null,{"inclusion":84,"exclusion":90,"raw_text":97},[85,86,87,88,89],"Hereditary Pancreatitis or","Peutz-Jeghers Syndrome or","Strong family history of pancreas cancer on one side of the family tree or","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","Endoscopic evaluation of pancreas scheduled",[91,92,93,94,95,96],"Medical comorbidities or coagulopathy that contraindicate endoscopy","Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis","Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope","Poor performance status","Inability to provide informed consent","Pregnancy.","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.",[99,100],"ADULT","OLDER_ADULT",[102,120,138,158,173,186,196,215,233],{"facility":103,"status":7,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":117},"Yale University","New Haven","Connecticut","06520","United States",[109,114],{"name":110,"role":111,"phone":112,"email":113},"Scott Merenda, BSN","CONTACT","203-785-7019","scott.merenda@yale.edu",{"name":115,"role":116},"James Farrell, MD","PRINCIPAL_INVESTIGATOR",{"lat":118,"lon":119},41.30815,-72.92816,{"facility":121,"status":7,"city":122,"state":123,"zip":124,"country":107,"contacts":125,"geoPoint":135},"Johns Hopkins Hospital","Baltimore","Maryland","21287",[126,130,132],{"name":127,"role":111,"phone":128,"email":129},"Hilary Cosby, RN, CGRN","410-502-2893","hcosby1@jhmi.edu",{"name":131,"role":116},"Michael Goggins, MD",{"name":133,"role":134},"Marcia I Canto, MD","SUB_INVESTIGATOR",{"lat":136,"lon":137},39.29038,-76.61219,{"facility":139,"status":7,"city":140,"state":141,"zip":142,"country":107,"contacts":143,"geoPoint":155},"Dana Farber Cancer Center, Harvard University","Boston","Massachusetts","02215",[144,148,151,153],{"name":145,"role":111,"phone":146,"email":147},"Samantha Kuney","617-632-4788","Samantha_Kuney@dfci.harvard.edu",{"name":149,"role":111,"email":150},"Ethan Provost","ethan_provost@dfci.harvard.edu",{"name":152,"role":116},"Sapna Syngal, MD",{"name":154,"role":134},"Matthew Yurgelun, MD",{"lat":156,"lon":157},42.35843,-71.05977,{"facility":159,"status":7,"city":160,"state":161,"zip":162,"country":107,"contacts":163,"geoPoint":170},"University of Michigan","Ann Arbor","Michigan","48109",[164,168],{"name":165,"role":111,"phone":166,"email":167},"Sarah Volk","734-998-1274","stomanic@med.umich.edu",{"name":169,"role":134},"Elena Stoffel, MD",{"lat":171,"lon":172},42.27756,-83.74088,{"facility":174,"status":7,"city":175,"state":175,"zip":176,"country":107,"contacts":177,"geoPoint":183},"NYU Langone Medical Center","New York","10016",[178,181],{"name":179,"role":111,"email":180},"Emil Agarunov","emil.agarunov@nyulangone.org",{"name":182,"role":116},"Tamas Gonda, MD",{"lat":184,"lon":185},40.71427,-74.00597,{"facility":187,"status":7,"city":175,"state":175,"zip":188,"country":107,"contacts":189,"geoPoint":195},"Columbia University Medical Center","10032",[190,193],{"name":191,"role":111,"email":192},"Katharine Godfrey","kb3217@cumc.columbia.edu",{"name":194,"role":116},"Fay Kastrinos, MD",{"lat":184,"lon":185},{"facility":197,"status":7,"city":198,"state":199,"zip":200,"country":107,"contacts":201,"geoPoint":212},"Case Comprehensive Cancer Center, Case Western Medical Reserve","Cleveland","Ohio","44106",[202,206,210],{"name":203,"role":111,"phone":204,"email":205},"Barbara Heaton","216-844-7314","Barbara.Heaton@UHhospitals.org",{"name":207,"role":111,"phone":208,"email":209},"Wendy Brock, RN","216-844-3853","wendy.Brock@UHhospitals.org",{"name":211,"role":134},"Amitabh Chak, MD",{"lat":213,"lon":214},41.4995,-81.69541,{"facility":216,"status":7,"city":217,"state":218,"zip":219,"country":107,"contacts":220,"geoPoint":230},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[221,225,228],{"name":222,"role":111,"phone":223,"email":224},"Daniel Clay","215-360-0905","Daniel.Clay@Pennmedicine.upenn.edu",{"name":226,"role":111,"email":227},"Sara Karley","sara.karley@pennmedicine.upenn.edu",{"name":229,"role":134},"Bryson Katona, MD",{"lat":231,"lon":232},39.95238,-75.16362,{"facility":234,"status":7,"city":235,"state":218,"zip":236,"country":107,"contacts":237,"geoPoint":246},"University of Pittsburgh","Pittsburgh","15213",[238,241,244],{"name":239,"role":111,"email":240},"Christine Decapite","decapitec@upmc.edu",{"name":242,"role":111,"email":243},"Sara Booz","boozs@upmc.edu",{"name":245,"role":116},"Randall Brand, MD",{"lat":247,"lon":248},40.44062,-79.99589,[250],{"name":251,"role":111,"email":129},"Hilary Cosby, RN",[253],{"name":131,"affiliation":12,"role":116},[255,259,262,265],{"pmid":256,"type":257,"citation":258},"34149034","DERIVED","Kumar S, Saumoy M, Oh A, Schneider Y, Brand RE, Chak A, Ginsberg GG, Kochman ML, Canto MI, Goggins MG, Hur C, Kastrinos F, Katona BW, Rustgi AK. Threshold Analysis of the Cost-effectiveness of Endoscopic Ultrasound in Patients at High Risk for Pancreatic Ductal Adenocarcinoma. Pancreas. 2021 Jul 1;50(6):807-814. doi: 10.1097\u002FMPA.0000000000001835.",{"pmid":260,"type":257,"citation":261},"33161160","Kohi S, Macgregor-Das A, Dbouk M, Yoshida T, Chuidian M, Abe T, Borges M, Lennon AM, Shin EJ, Canto MI, Goggins M. Alterations in the Duodenal Fluid Microbiome of Patients With Pancreatic Cancer. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e196-e227. doi: 10.1016\u002Fj.cgh.2020.11.006. Epub 2020 Nov 5.",{"pmid":263,"type":257,"citation":264},"31676359","Abe T, Koi C, Kohi S, Song KB, Tamura K, Macgregor-Das A, Kitaoka N, Chuidian M, Ford M, Dbouk M, Borges M, He J, Burkhart R, Wolfgang CL, Klein AP, Eshleman JR, Hruban RH, Canto MI, Goggins M. Gene Variants That Affect Levels of Circulating Tumor Markers Increase Identification of Patients With Pancreatic Cancer. Clin Gastroenterol Hepatol. 2020 May;18(5):1161-1169.e5. doi: 10.1016\u002Fj.cgh.2019.10.036. Epub 2019 Oct 30.",{"pmid":266,"type":257,"citation":267},"31197699","Canto MI, Kerdsirichairat T, Yeo CJ, Hruban RH, Shin EJ, Almario JA, Blackford A, Ford M, Klein AP, Javed AA, Lennon AM, Zaheer A, Kamel IR, Fishman EK, Burkhart R, He J, Makary M, Weiss MJ, Schulick RD, Goggins MG, Wolfgang CL. Surgical Outcomes After Pancreatic Resection of Screening-Detected Lesions in Individuals at High Risk for Developing Pancreatic Cancer. J Gastrointest Surg. 2020 May;24(5):1101-1110. doi: 10.1007\u002Fs11605-019-04230-z. Epub 2019 Jun 13.",[],{"nct_id":4,"conditions":270,"biomarkers":276},[271,272,273,274,22,275,57],"Ataxia Telangiectasia Syndrome","Breast Carcinoma","Familial Atypical Multiple Mole-Melanoma","Hereditary Pancreatitis","Pancreatic Carcinoma",[277,278,279,280,281,282,283,284,285,286,287,288,289,290],"ATM Gene","BRCA1 Gene","BRCA2 Gene","CDKN2A Gene","CFTR Gene","DNA Mismatch Repair Protein Mlh1","EPCAM Gene","MSH2 Gene","MSH6 Gene","Pancreatic Secretory Trypsin Inhibitor","Partner and Localizer of BRCA2","PMS2 Gene","Trypsin-1","Trypsin-2",{"nct_id":4,"found":292,"summary":293,"prompt_version":303},true,{"design":294,"status":295,"heading":296,"summary":297,"follow_up":298,"word_count":299,"commitments":300,"compensation":301,"drugs_mentioned":302},"This is an interventional study with a planned enrollment of 9000 participants. It is not specified if it's randomized or blinded.","completed","CAPS5 Study: Screening for Pancreatic Cancer in High-Risk Individuals","This study, called CAPS5, is looking for early signs of pancreatic cancer in people who have a higher risk of developing it. Researchers will use Secretin (a drug injected to stimulate pancreatic fluid) and collect this fluid to check for biomarkers (substances that can indicate disease). They will also use MRI (a type of imaging scan) if certain blood test results (CA-19-9) are abnormal, and a special gene test for CA-19-9 to understand individual levels. The study aims to find early cancer markers in pancreatic fluid over 10 years. You might be able to join if you are 18 or older and have conditions like hereditary pancreatitis, Peutz-Jeghers Syndrome, a strong family history of pancreatic cancer, or a confirmed gene mutation (like BRCA1, BRCA2, or Lynch Syndrome).","The study will evaluate pancreatic juice for early cancer markers over 10 years.",127,"You would receive an injection of Secretin, have pancreatic fluid collected, and potentially undergo an MRI abdomen with contrast. A tumor marker gene test for CA19-9 will also be performed.","Not stated in the trial record.",[46,62],"v2"]