[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07212491":3,"trial-entities:NCT07212491":113,"trial-summary:NCT07212491":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":74,"locations":77,"central_contacts":103,"overall_officials":104,"references":108,"see_also_links":109},"NCT07212491","SOS6C","Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma","Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma- Renewal Grant Aim 2 (The SOS6C Trial)","ENROLLING_BY_INVITATION","2030-07-31","2026-05","2026-05-06","2025-11-17","Mayo Clinic","OTHER",true,"This study explores the use of a minimally invasive screening tool (a sponge on a string device) to detect Barrett's esophagus and esophageal adenocarcinoma and to develop a laboratory test for the detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.",null,[19,20],"Barrett Esophagus","Esophageal Adenocarcinoma",[],"OBSERVATIONAL",[],{"count":25,"type":26},450,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"Non-Interventional Study","Non-interventional study",[32],"Observational",[34,35],"Non-Interventional Observational Study","Noninterventional (Observational) Study",[37,41],{"measure":38,"description":39,"timeFrame":40},"Sensitivity of deoxyribonucleic acid (DNA) markers","Will evaluate the sensitivity of DNA makers (methylated DNA markers ± aneuploidy) to distinguish between high-grade dysplasia (HGD)\u002Fesophageal adenocarcinoma (EAC) and non-dysplastic Barrett's esophagus (BE).","Baseline",{"measure":42,"description":43,"timeFrame":40},"Specificity of DNA markers","Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD\u002FEAC and non-dysplastic BE.",[],"ALL","18 Years","90 Years",false,{"inclusion":50,"exclusion":55,"raw_text":73},[51,52,53,54],"Patient between the ages 18 - 90","Patients with a BE segment \\>= 1cm in maximal extent endoscopically","Histology showing evidence of intestinal metaplasia with or without presence of dysplasia","Undergoing clinically indicated endoscopy",[56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded","Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma","Subjects with known evidence of BE (on history or review of medical records)","Pregnant or lactating females","Patients who are unable to consent","Patients with a current history of uninvestigated dysphagia (this does not apply to the brushings\u002Fbiopsies only portion of the study for RST\u002FARZ sites only)","History of eosinophilic esophagitis or achalasia","Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing\u002Fbiopsy only portion of the study for RST\u002FARZ sites only)","Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing\u002Fbiopsy only portion of the study for RST\u002FARZ sites only)","Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing\u002Fbiopsy only portion of the study for RST\u002FARZ sites only)","Patients with a history of known esophageal or gastric varices or cirrhosis","Patients with a history of esophageal or gastric resection","Patients with congenital or acquired bleeding diatheses","Patients with a history of esophageal squamous dysplasia","Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment","Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer","Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome","Inclusion Criteria:\n\n* Patient between the ages 18 - 90\n* Patients with a BE segment \\>= 1cm in maximal extent endoscopically\n* Histology showing evidence of intestinal metaplasia with or without presence of dysplasia\n* Undergoing clinically indicated endoscopy\n\nExclusion Criteria:\n\n* Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded\n* Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma\n* Subjects with known evidence of BE (on history or review of medical records)\n\n  * Pregnant or lactating females\n  * Patients who are unable to consent\n  * Patients with a current history of uninvestigated dysphagia (this does not apply to the brushings\u002Fbiopsies only portion of the study for RST\u002FARZ sites only)\n  * History of eosinophilic esophagitis or achalasia\n  * Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing\u002Fbiopsy only portion of the study for RST\u002FARZ sites only)\n  * Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing\u002Fbiopsy only portion of the study for RST\u002FARZ sites only)\n  * Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing\u002Fbiopsy only portion of the study for RST\u002FARZ sites only)\n  * Patients with a history of known esophageal or gastric varices or cirrhosis\n  * Patients with a history of esophageal or gastric resection\n  * Patients with congenital or acquired bleeding diatheses\n  * Patients with a history of esophageal squamous dysplasia\n  * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment\n  * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer\n  * Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome",[75,76],"ADULT","OLDER_ADULT",[78,87,95],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"geoPoint":84},"Mayo Clinic in Arizona","Scottsdale","Arizona","85259","United States",{"lat":85,"lon":86},33.50921,-111.89903,{"facility":88,"city":89,"state":90,"zip":91,"country":83,"geoPoint":92},"Mayo Clinic in Florida","Jacksonville","Florida","32224-9980",{"lat":93,"lon":94},30.33218,-81.65565,{"facility":96,"city":97,"state":98,"zip":99,"country":83,"geoPoint":100},"Mayo Clinic in Rochester","Rochester","Minnesota","55905",{"lat":101,"lon":102},44.02163,-92.4699,[],[105],{"name":106,"affiliation":13,"role":107},"Prasad G. Iyer, MD","PRINCIPAL_INVESTIGATOR",[],[110],{"label":111,"url":112},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":114,"biomarkers":115},[19,20],[],{"nct_id":4,"found":48,"summary":17,"prompt_version":17}]