[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470968":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":41,"responsibleParty":62,"collaborators":64,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":39,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":39,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":39,"overallStatus":44,"whyStopped":39,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Oesophageal\u002FGOJ cancer","EXPERIMENTAL","AROMA 1: 216 treatment naive patients with oesophageal\u002FGOJ cancer will be recruited to undertake an augmented breath test.\n\nBIORESOURCE: 110 treatment naive patients with oesophageal\u002FGOJ cancer will be recruited for biosample collection at the time of their staging laparoscopy procedure.",[13],"Dietary Supplement: Oral Stimulant Drink",{"label":15,"type":10,"description":16,"interventionNames":17},"Gastric cancer","AROMA 1: 216 treatment naive patients with gastric cancer will be recruited to undertake an augmented breath test.\n\nBIORESOURCE: 75 treatment naive patients with gastric cancer will be recruited for biosample collection at the time of their staging laparoscopy procedure.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Control\u002F normal patients with upper gastrointestinal symptoms","AROMA 1: 216 control subjects will be recruited to undertake an augmented breath test.\n\nBIORESOURCE: 150 control subjects will be recruited for biosample collection at the time of their routine endoscopy procedure.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIETARY_SUPPLEMENT","Oral Stimulant Drink","For the AROMA 1 study patients will be requested to consume a nutrient drink (approximately 200 ml) that includes natural ingredients found within a typical human diet. Following consumption of the drink, serial breath tests will be performed to determine varying levels of VOC production in breath",[19,15,9],[29],"Oral Nutrient Drink",[31],{"name":32,"affiliation":5,"role":33},"George Hanna, PhD, FRCS","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Ayushi Pabari, BSc, MSc","CONTACT","02075948847",null,"aroma@imperial.ac.uk",[42],{"facility":43,"status":44,"city":45,"state":39,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Imperial College NHS Foundation Trust","RECRUITING","London","W12 0HS","United Kingdom","UK",{"type":50,"coordinates":51},"Point",[52,53],-0.12574,51.50853,{"lat":53,"lon":52},[56,59],{"name":32,"role":37,"phone":57,"phoneExt":39,"email":58},"02033122124","g.hanna@imperial.ac.uk",{"name":60,"role":37,"phone":57,"phoneExt":39,"email":61},"Piers Boshier, PhD, FRCS","prb03@ic.ac.uk",{"type":63,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[65,67,69,71,73,75,77,79,81,83,85,88,90,92,94,96,98,100,102,104],{"name":66,"class":6},"Imperial College Healthcare NHS Trust",{"name":68,"class":6},"Newcastle-upon-Tyne Hospitals NHS Trust",{"name":70,"class":6},"University Hospital Birmingham NHS Foundation Trust",{"name":72,"class":6},"University Hospital Southampton NHS Foundation Trust",{"name":74,"class":6},"Norfolk and Norwich University Hospitals NHS Foundation Trust",{"name":76,"class":6},"Nottingham University Hospitals NHS Trust",{"name":78,"class":6},"University Hospital Plymouth NHS Trust",{"name":80,"class":6},"Royal Surrey County Hospital NHS Foundation Trust",{"name":82,"class":6},"University Hospitals Coventry and Warwickshire NHS Trust",{"name":84,"class":6},"Guy's and St Thomas' NHS Foundation Trust",{"name":86,"class":87},"Portsmouth Hospitals NHS Trust","OTHER_GOV",{"name":89,"class":6},"Barking, Havering and Redbridge University Hospitals NHS Trust",{"name":91,"class":6},"Northern Care Alliance NHS Foundation Trust",{"name":93,"class":6},"Brighton and Sussex University Hospitals NHS Trust",{"name":95,"class":6},"University College London Hospitals",{"name":97,"class":87},"Cardiff and Vale University Health Board",{"name":99,"class":87},"NHS Lothian",{"name":101,"class":87},"NHS Tayside",{"name":103,"class":6},"York Teaching Hospitals NHS Foundation Trust",{"name":105,"class":6},"The Harley Street Clinic","100470968","augmented-response-of-volatile-biomarkers-in-assessment-of-oesophagogastric-cancer-aroma-1--bioresource-100470968",false,"NCT05412758","Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 \u002F BIORESOURCE)","Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer","AROMA 1 Inclusion Criteria:\n\n1. Aged 18-90years\n2. Oesophageal\u002Fgastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve\n3. Control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Endoscopy within 1 year • Planned endoscopy\n\nAROMA 1 Exclusion criteria:\n\nPatients with the following characteristics will not be eligible for inclusion in this study:\n\n1. Oesophageal squamous cell carcinoma\n2. Previous oesophageal and gastric resection\n3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer\n4. History of another cancer within three years\n5. Any form of oesophageal dysplasia (control cohort only)\n6. Previously diagnosed with Barrett's oesophagus (control cohort only)\n7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks\n8. Participants with co-morbidities preventing breath collection\n9. Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid\n10. Unable or unwilling to provide informed written consent\n11. Pregnant participants\n\nBIORESOURCE inclusion criteria:\n\n1. Aged 18- 90years\n2. Oesophageal\u002Fgastric cancer cohort: participants with biopsy proven adenocarcinoma who are treatment naïve\n3. Oesophageal\u002Fgastric control cohort: participants with normal or benign upper gastrointestinal disease determined on: • Planned endoscopy\n\nBIORESOURCE exclusion criteria:\n\n1. Oesophageal squamous cell carcinoma\n2. Previous oesophageal and gastric resection\n3. Received neoadjuvant chemotherapy for oesophageal or gastric cancer\n4. History of another cancer within five years\n5. Any form of oesophageal dysplasia (oesophageal\u002Fgastric control cohorts only)\n6. Previously diagnosed with Barrett's oesophagus (oesophageal\u002Fgastric control cohorts only)\n7. Active infection, on immunosuppressive medications or antibiotic therapy within the last 8 weeks\n8. Participants with co-morbidities preventing breath collection\n9. Unable or unwilling to provide informed written consent\n10. Pregnant participants",true,"ALL","18 Years","90 Years",{"count":118,"type":119},648,"ESTIMATED","INTERVENTIONAL",[122],"NA","Cancer of the stomach and oesophagus is among the world's top five cancers. Survival rates are very poor as the disease presents late and early symptoms are non-specific. The study team has developed a non-invasive test for cancers of the stomach and oesophagus based on the detection of volatile organic compounds in exhaled breath. These compounds are known to be produced by both cancers as well as cancer associated bacteria within the gut.\n\nThe proposed innovation is to improve the accuracy of this test by investigating whether simple metabolic substrates can increase the production of these volatile organic compounds by both the tumour and its associated bacteria.",[125,126,127,128,129,130,131,132,133,134],"Volatile Organic Compounds","Microbiome","Microbioata","Breath Analysis","Oesophageal Cancer","Gastric Cancer","Volatalomics","Metabonomics\u002FLipidomics","Microbiome Analysis","Transcriptomics","2025-01-29",{"date":137,"type":138},"2025-01-31","ACTUAL",{"date":140,"type":138},"2022-02-28",{"date":142,"type":119},"2025-10",{"name":5,"class":6},1]