[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transcriptomics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transcriptomics":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100637308","how-gut-health-affects-immune-responses-to-the-oral-rotavirus-vaccine-in-adults-in-zambia-100637308",false,"NCT07626606","How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia","Temporal and Spatial Immune Profiling of Oral Rotavirus Vaccine Responses in Zambian Adults With Environmental Enteropathy","Rota-Omics","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 50 years.\n* Able and willing to provide written informed consent.\n* Reside within Lusaka district and available for scheduled follow-up.\n* Willing to undergo two endoscopy procedures with serial sample collection.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding).\n* Known severe immunodeficiency (HIV with CD4 \\\u003C 200 cells\u002Fmm³, current cancer chemotherapy, systemic corticosteroids equivalent to \\>20 mg\u002Fday prednisolone for \\>2 weeks).\n* Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities).\n* Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated.\n* Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration.\n* Any condition judged by the investigator to compromise participant safety or data integrity.\n* Participants who had a recent diarrhoea episode, or who have taken NSAID drugs or antibiotics, will be eligible for re-assessment after a month without this disqualifier.\n\nPregnancy testing and counselling: Women of reproductive potential will require a negative urine pregnancy test within 24 hours prior to endoscopy and vaccination and will be counselled to avoid pregnancy during the first 30 days post-vaccination.",true,"ALL","18 Years","50 Years",{"count":22,"type":23},43,"ESTIMATED","OBSERVATIONAL","The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Rotavirus remains one of the leading causes of severe diarrheal disease in infants and young children worldwide, despite the widespread introduction of vaccines such as Rotarix® and Rotavac®. Although these vaccines have greatly reduced childhood deaths in many countries, vaccine effectiveness is often lower in settings where the burden of disease is highest. Understanding the reasons behind this reduced protection is critical for improving child health globally.\n\nA major focus of the study is Environmental Enteropathy (EE), also known as Environmental Enteric Dysfunction (EED), a chronic inflammatory condition of the small intestine that is common in low-resource settings. EE is associated with damage to the intestinal lining, chronic immune activation, poor nutrient absorption, and impaired gut barrier function. These changes are thought to interfere with the body's ability to respond effectively to oral vaccines, which rely on strong intestinal immune responses.\n\nThe RotaOmics study uses a systems biology approach to investigate how the immune system, gut microbiome, nutrition, and intestinal inflammation interact to influence rotavirus vaccine responses. The term \"omics\" refers to advanced technologies that allow researchers to study genes, proteins, microbes, and other biological processes at a large scale. By combining these approaches, the study aims to identify biological markers and immune pathways associated with strong or weak vaccine responses.\n\nThe study involves the collection of samples such as blood, stool, saliva, and breast milk from mothers and infants at different time points before and after vaccination. These samples are analysed using laboratory methods including antibody testing, molecular pathogen detection, microbiome sequencing, and immune profiling. The study also evaluates markers of gut inflammation and intestinal health.\n\nOne important goal of the project is to identify correlates of protection, which are measurable biological indicators that predict whether a vaccine is likely to protect against disease. Identifying these markers could help guide the development of improved vaccines or supportive interventions to enhance vaccine performance in vulnerable populations.\n\nThe study also contributes to a broader understanding of mucosal immunity, which refers to immune responses occurring in the gastrointestinal tract. Since many enteric infections begin in the gut, understanding intestinal immune function is important not only for rotavirus vaccines but also for other oral vaccines and diarrheal diseases.\n\nIn addition to its scientific objectives, RotaOmics includes a strong capacity-building component. The project supports training for local scientists, clinicians, and laboratory personnel in areas such as molecular biology, immunology, genomics, bioinformatics, and data analysis. By strengthening local research expertise and infrastructure, the study aims to support long-term scientific development and improve regional capacity for infectious disease research and outbreak response.\n\nOverall, the RotaOmics study seeks to generate new insights into why oral rotavirus vaccines underperform in some settings and to identify strategies that may improve vaccine effectiveness and child health outcomes in Zambia and similar regions worldwide.",[27,28,29,30],"Feasibility Study","Vaccine Immune Response","Rota Virus Gastroenteritis","Transcriptomics",[30,32,33,34,35,36],"Feasibility","Microbiome","Immunity","Rotavirus","Vaccine","RECRUITING","2026-06-02",{"date":40,"type":41},"2026-06-04","ACTUAL",{"date":43,"type":41},"2026-03-30",{"date":45,"type":23},"2026-12-31",{"name":47,"class":48},"Centre for Infectious Disease Research in Zambia","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":49},"100470968","augmented-response-of-volatile-biomarkers-in-assessment-of-oesophagogastric-cancer-aroma-1--bioresource-100470968","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","90 Years",{"count":59,"type":23},648,"INTERVENTIONAL",[62],"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.",[65,33,66,67,68,69,70,71,72,30],"Volatile Organic Compounds","Microbioata","Breath Analysis","Oesophageal Cancer","Gastric Cancer","Volatalomics","Metabonomics\u002FLipidomics","Microbiome Analysis","2025-01-29",{"date":75,"type":41},"2025-01-31",{"date":77,"type":41},"2022-02-28",{"date":79,"type":23},"2025-10",{"name":81,"class":48},"Imperial College London",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":60,"phases":91,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":49},"100550669","study-of-the-relationship-between-clinical-imaging-and-biological-data-in-patients-with-squamous-cell-carcinoma-of-the-tongue-100550669","NCT06450080","Study of the Relationship Between Clinical, Imaging and Biological Data in Patients With Squamous Cell Carcinoma of the Tongue","ClimaBio","Inclusion Criteria:\n\nPatients:\n\n* Patients from the maxillofacial surgery department of the Amiens-Picardie University Hospital treated for histologically confirmed squamous cell carcinoma of the tongue\n* Patients who have not yet been treated, either surgically or by neoadjuvant treatment\n* Patients with a tumor of minimum dimensions of 15 mm in long axis\n* Patients without contraindication to MRI\n* Patients over 18 years old\n* Patients who have provided free and informed written consent\n* Patients benefiting from a social security system\n\nHealthy volunteers:\n\n* Subjects without a history of cancer of the upper aerodigestive tract\n* Subjects without contraindication to MRI\n* Subjects over 18 years old\n* Subjects who have provided free and informed written consent\n* Subjects benefiting from a social security system\n\nExclusion Criteria:\n\n* Patients:\n* Patients with a lingual tumor measuring less than 15 mm in long axis\n\nPatients and healthy volunteers:\n\n* Patients with other histological types of cancer, or other locations\n* Subjects with a contraindication to MRI\n* Subjects under 18 years old\n* Pregnant or breastfeeding women\n* Persons under guardianship, curators, protection of justice or deprived of liberty",{"count":90,"type":23},60,[62],"Squamous cell carcinoma (SCC) could be a very aggressive cancer and has a bad prognosis if not detected early and thus is associated with high mortality. The development of simple and reliable biomarkers for the early detection of SCC is one of the solutions to better diagnose, treat these tumors, evaluate and monitor treatments, and hence reduce mortality. In a previous work, the investigators demonstrated the ability of Proton Magnetic resonance spectroscopy (1H-MRS) to non-invasively assess spectroscopic and metabolic profiles of tongue tissue in healthy subjects. In the present work, the investigators challenge the use of in-vivo 1H-MRS as a potential method for non-invasive metabolic monitoring of patients with squamous cell carcinoma of the tongue undergoing therapy. Thus the main objective is to study the spectroscopic and metabolic differences, e.g. including variation in the metabolite TMA-Cho (trimethylamine-choline), of tongue tissue between healthy subjects and in patients with squamous cell carcinoma of the tongue, before and after surgery.",[94,95,96,30],"Soft Tissue Tumors of the Tongue","Squamous Cell Carcinoma","Proton Magnetic Resonance Spectroscopy",[98,95,99,100,101,102,30],"Tongue tissue","proton magnetic resonance spectroscopy","1H-MRS","spectroscopic and metabolic profile","noninvasive biomarkers","2024-06-04",{"date":105,"type":41},"2024-06-10",{"date":107,"type":41},"2024-03-27",{"date":109,"type":23},"2026-06",{"name":111,"class":48},"Centre Hospitalier Universitaire, Amiens"]