[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548247":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":37,"responsibleParty":38,"collaborators":40,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":37,"enrollmentInfo":54,"targetDuration":37,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":69,"whyStopped":37,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":37},{"fullName":5,"class":6},"Centre of Postgraduate Medical Education","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Capsule-sponge","EXPERIMENTAL","This part of the study will have an active prospective recruitment of patients. Recruitment will involve three patient populations:\n\n1. Patients with ESCC\n2. Patients at high risk for ESCC\n3. Healthy controls\n\nFollowing inclusion in the study, subjects will be asked to complete a behavior questionnaire, have blood collected, and undergo a capsule-sponge procedure followed by diagnostic gastroscopy using advanced imaging with biopsies. During gastroscopy, additional tissue samples will be collected for research purposes. These samples, along with cytological specimens from the capsule-sponge, will be analyzed to assess the diagnostic accuracy of biomarkers in the diagnosis of esophageal squamous neoplasia.",[13],"Device: Capsule-sponge",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The capsule-sponge is a minimally-invasive sampling device consisting of a polyurethane sponge compressed in a cellophane capsule attached to a string. When swallowed, the capsule dissolves in the stomach, releasing the cell collection sponge that expands to 3 cm in diameter. Next, a nurse or qualified medical technician retrieves the sponge by pulling back on the string and retracting it through the mouth. During extraction, the rough texture on the surface of the sponge collects epithelial cells in the cardia and along the entire length of the esophagus.",[9],[20,21,22],"Upper endoscopy with biopsies","Blood collection","throat swab",[24],{"name":25,"affiliation":26,"role":27},"Wladyslaw Januszewicz, M.D., PhD","Centre of Postgraduate Medical Education, Warsaw, Poland","PRINCIPAL_INVESTIGATOR",[29,34],{"name":25,"role":30,"phone":31,"phoneExt":32,"email":33},"CONTACT","+48225462328","+48","wjanuszewicz@cmkp.edu.pl",{"name":35,"role":30,"phone":31,"phoneExt":32,"email":36},"Jaroslaw Regula, M.D., PhD","jaroslaw.regula@coi.pl",null,{"type":39,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[41],{"name":42,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology","100548247","early-detection-of-esophageal-squamous-cancer-with-the-capsule-sponge-device-100548247",false,"NCT06418516","Early Detection of Esophageal Squamous Cancer With the Capsule Sponge Device","Early Detection of Esophageal Squamous Cell Carcinoma With the Capsule Sponge Device Coupled With Molecular Biomarkers and Machine Learning","ANGELA","Inclusion Criteria:\n\n1. Patients with esophageal squamous cell cancer (ESCC):\n\n   * Patients ≥18 years of with adequate performance status for endoscopy\n   * Newly diagnosed ESCC suitable for endoscopic or oncological treatment (Rth\u002FChth)\n   * Patients currently undergoing oncological treatment (Rth\u002FChth)\n   * Consent to provide tissue samples for the study\n   * Dysphagia grade ≤2 (able to swallow mixed foods and tablets)\n2. Patients at high risk for ESCC:\n\n   * Patients ≥18 years of age with adequate performance status for endoscopy\n   * Prior definitive treatment for head and neck cancer (cancer of the oral cavity, hypopharyngeal cancer, laryngeal carcinoma) and at least 12 months post-therapy (both Rth, Chth, and combination treatment)\n   * Prior definitive endoscopic treatment for early ESCC in the past (at least 6 months since completion)\n   * Consent to provide tissue samples for the study\n   * Dysphagia grade ≤2\n3. Healthy controls - Patients ≥18 years old undergoing endoscopic evaluation for typical GI symptoms other than dysphagia (e.g., GERD, dyspepsia, etc.) without significant risk factors for ESCC\n\nExclusion Criteria (for all patients):\n\n* Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping \u002F modification\n* Dysphagia grade ≥3 (able to swallow only liquid foods)\n* History of myocardial infarction or other cardiovascular event within 6 months of enrolment\n* Neurological diseases associated with impaired swallowing\n* Patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability).",true,"ALL","18 Years",{"count":55,"type":56},340,"ESTIMATED","INTERVENTIONAL",[59],"NA","Esophageal squamous cell carcinoma accounts for \\~90% of the nearly half-million annual incident cases of esophageal cancer worldwide. The high costs and invasiveness of upper endoscopy constitute a limitation in providing adequate surveillance for at-risk individuals, including those with previous head and neck cancer. The ANGELA study is a prospective evaluation of the minimally-invasive capsule-sponge device, coupled with tissue biomarkers (p53-immunohistochemistry), to detect squamous neoplasia in high-risk individuals.",[62,63,64],"Esophageal Cancer","Head and Neck Cancer","Squamous Cell Carcinoma",[66,67,62,68],"Prevention","Screening","Capsule Sponge","NOT_YET_RECRUITING","2024-05-13",{"date":72,"type":73},"2024-05-17","ACTUAL",{"date":75,"type":56},"2024-06-01",{"date":77,"type":56},"2027-06-01",{"name":5,"class":6}]