[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495118":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":41,"centralContacts":45,"locations":53,"responsibleParty":69,"collaborators":71,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":118,"sex":119,"minAge":120,"maxAge":10,"enrollmentInfo":121,"targetDuration":10,"studyType":124,"phases":10,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14,18,22,27],{"label":9,"type":10,"description":11,"interventionNames":12},"VAPOR 1 - PDAC (pancreatic ductal adenocarcinoma)",null,"304 treatment-naive patients with histologically-confirmed\\* PDAC will be recruited to provide breath samples.\n\n\\*Patients that are due to undergo surgery for suspected PDAC (without pre-operative histological confirmation) may still be recruited despite the lack of pre-operative histological confirmation, assuming PDAC is subsequently confirmed within the resected specimen.",[13],"Diagnostic Test: Breath test",{"label":15,"type":10,"description":16,"interventionNames":17},"VAPOR 1 - Control patients with benign pancreatic disorders","257 patients with new-onset diabetes mellitus or chronic pancreatitis will be recruited to provide breath samples.\n\nNew-onset diabetes is defined as: HbA1c≥48mmol\u002Fmol (6.5%), diagnosed within the preceding 6 months.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"VAPOR 1 - Control patients with non-specific GI symptoms and a normal pancreas","257 patients with non-specific gastrointestinal symptoms but a radiologically-normal pancreas will be recruited to provide breath samples.\n\nImaging to confirm a normal pancreas (CT \u002F MRI \u002F ultrasound) must have occurred within the preceding 12 months.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"VAPOR Bioresource - PDAC (pancreatic ductal adenocarcinoma)","96 treatment-naive patients with histologically-confirmed\\* PDAC will be recruited to provide samples of breath, saliva, blood, urine, pancreatic tissue and duodenal aspirate.\n\n\\*Patients that are due to undergo surgery for suspected PDAC (without pre-operative histological confirmation) may still be recruited despite the lack of pre-operative histological confirmation, assuming PDAC is subsequently confirmed within the resected specimen.",[26],"Diagnostic Test: Collection of matched samples of breath, biofluids and pancreatic tissue",{"label":28,"type":10,"description":29,"interventionNames":30},"VAPOR Bioresource - Control patients with benign pancreatic disorders","96 patients with benign pancreatic disorders (such as intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis) will be recruited to provide samples of breath, saliva, blood, urine, pancreatic tissue and duodenal aspirate.",[26],[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"DIAGNOSTIC_TEST","Breath test","Patients must be fasted for a minimum of six hours prior to sample collection. For patients undergoing surgery or a procedure (e.g. endoscopy), breath samples must be obtained pre-operatively \u002F prior to the administration of sedation, anaesthetic or other pharmacological agents.",[15,19,9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Collection of matched samples of breath, biofluids and pancreatic tissue","In accordance with routine clinical practices, patients will be fasted for a minimum of six hours prior to surgery. Exhaled breath, saliva, blood and urine will be collected immediately prior to surgery (before induction of general anaesthesia). Pancreatic tissue samples and duodenal aspirate which will be collected upon resection of the pancreatic specimen.",[28,23],[42],{"name":43,"affiliation":5,"role":44},"Professor George B Hanna, PhD, FRCS","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Miss Caoimhe M Walsh, MBBS, MRCS","CONTACT","+44 (0)20 7594 3653","vapor@imperial.ac.uk",{"name":52,"role":48,"phone":49,"phoneExt":10,"email":50},"Emma Austin",[54],{"facility":55,"status":56,"city":57,"state":10,"zip":10,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Imperial College Healthcare NHS Trust","RECRUITING","London","United Kingdom","UK",{"type":61,"coordinates":62},"Point",[63,64],-0.12574,51.50853,{"lat":64,"lon":63},[67],{"name":52,"role":48,"phone":68,"phoneExt":10,"email":50},"02075943653",{"type":70,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[72,74,75,77,80,82,84,86,88,90,92,94,96,98,100,102,104,106,108],{"name":73,"class":6},"Pancreatic Cancer UK",{"name":55,"class":6},{"name":76,"class":6},"Royal Free Hospital NHS Foundation Trust",{"name":78,"class":79},"Liverpool University Hospitals NHS Foundation Trust","OTHER_GOV",{"name":81,"class":6},"The Leeds Teaching Hospitals NHS Trust",{"name":83,"class":6},"Sheffield Teaching Hospitals NHS Foundation Trust",{"name":85,"class":6},"University Hospital Southampton NHS Foundation Trust",{"name":87,"class":6},"Royal Surrey County Hospital NHS Foundation Trust",{"name":89,"class":6},"University Hospital Birmingham NHS Foundation Trust",{"name":91,"class":79},"Manchester University NHS Foundation Trust",{"name":93,"class":6},"Newcastle-upon-Tyne Hospitals NHS Trust",{"name":95,"class":6},"Swansea Bay University Health Board",{"name":97,"class":79},"Dorset County Hospital NHS Foundation Trust",{"name":99,"class":6},"North Tees and Hartlepool NHS Foundation Trust",{"name":101,"class":6},"University Hospital Plymouth NHS Trust",{"name":103,"class":6},"Barts & The London NHS Trust",{"name":105,"class":79},"Milton Keynes University Hospital NHS Foundation Trust",{"name":107,"class":6},"Buckinghamshire Healthcare NHS Trust",{"name":109,"class":6},"Southern Health","100495118","volatile-organic-compound-assessment-in-pancreatic-ductal-adenocarcinoma-100495118",false,"NCT05727020","Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma","Volatile Organic Compound Assessment in Pancreatic Ductal Adenocarcinoma (VAPOR 1 \u002F BIORESOURCE)","VAPOR","Inclusion Criteria:\n\n* Males and females\n* Adult patients ≥ 18 years old\n* VAPOR 1: patients with either a) Histologically confirmed PDAC\\*; b) New-onset diabetes mellitus or chronic pancreatitis; or c) Non-specific gastrointestinal symptoms, but a radiologically-normal pancreas\n* VAPOR Bioresource: patients undergoing pancreatic resection for a) Histologically confirmed PDAC\\*; or b) Benign pancreatic disorders e.g. intraductal papillary mucinous neoplasms, pancreatic mucinous cystic neoplasms, chronic pancreatitis\n\nNote: \\*Patients undergoing surgery for suspected PDAC (without pre-operative histological confirmation) may be recruited assuming PDAC is confirmed within the resected specimen.\n\nExclusion Criteria:\n\n* Patients who have already received chemotherapy, radiotherapy or surgery for their PDAC\n* History of another cancer within the previous five years\n* Previous upper gastrointestinal surgery\n* Patients who are unable to provide a breath sample\n* Pregnant women\n* Patients unable to provide informed written consent\n* VAPOR 1: Patients with active infection, receiving immunosuppressive medications or antibiotics within the preceding eight weeks\n* VAPOR Bioresource: Patients receiving immunosuppressive medications within the preceding eight weeks",true,"ALL","18 Years",{"count":122,"type":123},1005,"ESTIMATED","OBSERVATIONAL","Patients with early pancreatic cancer often have symptoms that could also be caused by many common benign conditions, or no symptoms at all. Jaundice, weight loss and pain are 'red flag' symptoms of pancreatic cancer that are linked to incurable disease. At the moment only patients with 'red flag' symptoms are urgently referred for diagnostic testing to find out if they have the cancer. As a result, late diagnosis is a common feature of pancreatic cancer. This leads to limited treatment options being available to patients by the time they are diagnosed, and ultimately results in poor survival rates.\n\nThere is a clear need to improve earlier detection of pancreatic cancer so that patients with pancreatic cancer can be identified earlier and faster, enabling them to start treatment more quickly.\n\nThe study team is developing a non-invasive breath test that detects small molecules called volatile organic compounds (VOCs) that may be altered by pancreatic cancers. For patients with non-specific symptoms, this test would help general practitioners (GPs) to identify those patients that may indeed have an underlying pancreatic cancer, who would benefit from referral for specialised pancreatic cancer tests.",[127,128],"PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer",[130,131,132,133,134,135,136,137],"Volatile organic compounds (VOCs)","Breath analysis","Volatolomics","Metabonomics \u002F Lipidomics","Transcriptomics","Microbiome Analysis","Organoids","Immune profiling","2026-05-15",{"date":140,"type":141},"2026-05-18","ACTUAL",{"date":143,"type":141},"2022-12-15",{"date":145,"type":123},"2028-08",{"name":5,"class":6},1]