[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biomarker-in-early-diagnosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biomarker-in-early-diagnosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,70,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100639038","generating-intervals-of-reference-ffor-early-life-brain-biomarkers-100639038",false,"NCT07585149","Generating Intervals of Reference FFor Early Life Brain Biomarkers.","GIRAFFE","Inclusion Criteria:\n\n* Term neonate (≥37 weeks)\n* Planned routine venous blood drawn within one week of life\n* Relevant demographic\u002Fclinical information available, including gestational age, day of life, birth weight, sex, race, mode of delivery, and 5-minute Apgar score\n* Informed parental consent obtained prior to any study procedures\n\nExclusion Criteria:\n\n* Pre-term neonates \\\u003C37 weeks\n* Any clinical evidence of neurological\u002F CNS abnormalities.\n* NICU admission\n* Any neonates with Suspected or culture-positive sepsis or meningitis Any known inborn errors of metabolism (IEM). Any known chromosomal abnormalities or any apparent congenital abnormalities\n* When the relevant demographic\u002Fclinical information is not available.",true,"ALL","0 Days","7 Days",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","Highly sensitive immunoassays for the detection of neuro-specific biomarkers are becoming more accessible. Currently, the majority of these biomarkers are detected with the use of labour-intensive and highly skilled wet lab work. However, recent advancements have allowed for the introduction of these neuro-specific biomarkers into mainstream clinical chemistry analysers, bringing them closer to clinical care. There is a vast amount of published literature for neuro-specific biomarkers in an adult and ageing population, unfortunately, the same cannot be said for the neonatal population. From the limited available literature, clear differences are being documented in physiological levels of neuro-specific biomarkers in adults and infants. Neuro-specific biomarkers such as GFAP (Glial Fibrillary Acidic Protein) and Tau are demonstrating promise for the early detection and prediction of neuro-developmental disorders. There is a need for an understanding of physiological levels of these neuro-specific biomarkers in a neonatal population before they can be fully adopted into clinical routine. The development of a neonatal reference interval for neuro-specific biomarkers may provide a foundation for the accurate interpretation of neuro-specific biomarker elevations in neonatal brain injury, aiding in the development of biomarker-based screening tools for early diagnosis and intervention.",[26,27,28],"Reference Intervals","Biomarker in Early Diagnosis","Neonatal",[30,31,28,32],"Neurospecific","Biomarker","Reference Interval","RECRUITING","2026-05-08",{"date":36,"type":37},"2026-05-13","ACTUAL",{"date":39,"type":37},"2026-04-13",{"date":41,"type":22},"2027-06-30",{"name":43,"class":44},"University College Cork","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":56,"studyType":23,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":45},"100615505","discovery-and-validation-of-periodontitis-biomarkers-100615505","NCT07293481","Discovery and Validation of Periodontitis Biomarkers","Inclusion Criteria:\n\n1. Adults between 18 and 40 years of age;\n2. Diagnosed with varying degrees of periodontal disease, including gingivitis and stage I periodontitis;\n3. Voluntarily agree to participate in the study, have signed the informed consent form, and are able to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women;\n2. Individuals who have received antibiotic treatment within the past 3 months;\n3. Individuals who have received periodontal treatment (including supragingival scaling) within the past 6 months;\n4. Individuals with mucosal or salivary gland diseases (e.g., Sjögren's syndrome);\n5. Individuals with severe systemic diseases, immune dysfunction, or health conditions that contraindicate surgery;\n6. Individuals who are unwilling to cooperate with the study.","18 Years","40 Years",{"count":55,"type":22},228,"2 Years","Periodontitis is a major public health issue in China: it is responsible for loss of masticatory function in 60 million older adults, and 400-500 million adults are on the same disease trajectory. In addition, gingivitis and early-stage periodontitis are highly prevalent in all age groups. The Lancet 2021 burden of disease study provides worrying projections for China's oral health, with a 47.8% increase in advanced-stage periodontitis and a 217% increase in edentulism by the year 2050. The numbers are not manageable by the Chinese health system unless a series of coordinated actions are implemented: i) health education promoting oral hygiene in school and the workplace; ii) effective AI-based self-detection strategies and accurate identification of high-risk subjects; iii) efficient treatment modalities; and iv) reorganization of the health system.\n\nWe have developed, patented, and validated a self-detection AI-based screening test for the general population through an app. It is based on a few validated questions and the performance of a lateral flow immunoassay to detect activated matrix metalloproteinase 8 (aMMP8). The algorithm enables accurate self-detection of severe periodontitis. The system, however, cannot identify subjects without clinically evident periodontitis (subjects who present with superficial inflammation consistent with gingivitis and incipient periodontitis) who will develop the disease, which, therefore, should be the target of early interventions. This limitation is due to insufficient knowledge of the process that turns superficial inflammation (gingivitis) into periodontitis. This limitation is apparent in the recently published NIH-sponsored American diagnostic trial results to detect periodontitis onset biomarkers (and progression). In their study, Teles et al. (2024) show that almost 24% of gingivitis subjects progress to periodontitis over a 12-month period but failed to identify salivary or serum biomarkers. Similarly, our recently completed study (Li et al. in preparation) did not identify highly accurate biomarkers for disease onset and progression. Importantly, the American and our study have tested putative biomarkers identified based on the current crude knowledge of the disease process. Gaps in fundamental knowledge are now apparent and limit our ability to detect periodontitis early. In addition, the current crude differential diagnosis based on clinical examination with a periodontal probe with millimeter markings cannot accurately differentiate gingivitis from early-stage periodontitis, complicating the ground truth definition (gold standard).\n\nIn the current study, we propose implementing a multi-omics approach to test the ability to discriminate a mixed population of clinically undifferentiable gingivitis and stage I periodontitis into two or more clusters. In this biomarker discovery phase, we plan to use multiple state-of-the-art methods: i) laser scanning microdissection proteomics of tissue biopsies, ii) conventional salivary proteomics, iii) tissue biopsy transcriptomics, and iv) shotgun microbiome analysis. The methods will be applied in an agnostic approach to test the following hypotheses:\n\n1. It is possible to identify two or more clusters of subjects from a mixed population of gingivitis and stage I periodontitis subjects.\n2. The clusters differ based on host-derived biomarkers and\u002For microbiome factors and the risk of progression to periodontitis.\n3. The biomarker pathways and microbial virulence factors among subjects identified according to the different approaches used to explore disease biology are generally consistent.\n4. It is possible to identify a limited set of biomarkers that can be used to predict periodontitis onset and thus target early interventions for this high-risk population.",[59,27,60],"Periodontitis","Saliva","2026-04-17",{"date":63,"type":37},"2026-04-20",{"date":65,"type":37},"2025-07-21",{"date":67,"type":22},"2027-10-31",{"name":69,"class":44},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100623839","blood-biomarkers-for-early-and-accurate-diagnosis-of-alzheimers-disease-in-primary-care-100623839","NCT07401849","Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care","BEAD-PC","Inclusion Criteria:\n\n* Age 55 years and above\n* Presence of self-reported symptoms indicative of cognitive decline or concerns family members\u002Fpartners indicative of cognitive decline\n* Capacity to consent\n* Be fluent in and able to read and write in English and have adequate hearing and visual acuity to complete the required psychometric tests.\n\nExclusion Criteria:\n\n* Insufficient vision and hearing\n* Prior diagnosis of ADRD. Prior diagnosis of Alzheimer's disease or related dementia (with or without evidence of pathology), through clinical diagnosis and\u002For as documented in their medical record\n* Pre-existing diagnosis of dementia\n* Incidental findings of brain pathologies on brain MRI, such as cancerous space occupying lesions and clinically significant vascular malformations and recent (within 12 months) macro-infarcts, that are, also exclusionary\n* Contraindication for Lumbar Puncture\n* Involvement in interventional research study within 3 months prior to screening\n* For any other reason, in the opinion of the Investigator, participating in the study is not in the best interest of the patient.","55 Years",{"count":79,"type":22},1000,"Alzheimer's disease is a degenerative condition affecting the brain and is the most common form of dementia in older adults. Dementia is currently a major healthcare issue in the UK, affecting approximately a million people. The progression of the disease varies between individuals and the early stages may be characterised by only minimal changes in memory and thinking. These changes could remain undetected as the symptoms may be mistakenly regarded as normal age-related forgetfulness. However, dementia is not part of the normal ageing process.\n\nThe underlying biological disease process of Alzheimer's is now known to start at least 20 years prior to patients showing any symptoms. A protein called amyloid starts to deposit in the brain and forms clumps referred to as 'plaques'. Another protein called tau collects inside brain cells and forms structures called 'tangles'. These biological changes can disrupt the normal functioning of brain cells and ultimately destroy them, leading to a reduction in brain volume and ability.\n\nThe aim of the BEAD-PC study is to assess whether a specific blood test in primary care can help diagnose Alzheimer's disease at an early stage.",[82,83,27,84],"Alzheimer Disease","Biomarkers \u002F Blood","Mild Cognitive Impairment (MCI)",[86,87,88,89,90,91],"Alzheimer's Disease","Memory complaints","Mild Cognitive Impairment","Primary care","Blood biomarkers","Neuropsychological assessment","NOT_YET_RECRUITING","2026-02-06",{"date":95,"type":37},"2026-02-11",{"date":97,"type":22},"2026-02",{"date":99,"type":22},"2026-11",{"name":101,"class":44},"Imperial College London",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":16,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":45},"100620121","mir-342-5pankg-pathway-in-early-ad-synaptic-dysfunction-100620121","NCT07353502","miR-342-5p\u002FAnkG Pathway in Early AD Synaptic Dysfunction","Effects of miR-342-5p\u002FAnkG Pathway-Mediated Axon Initial Segment Filtering Injury on Early Synaptic Dysfunction in Alzheimer's Disease and Its Clinical Applications","Inclusion Criteria:\n\nInclusion criteria for AD group:\n\n1. Meet the diagnostic criteria for \"probable AD dementia\" established by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)\n2. MMSE score between 0-23 points, Clinical Dementia Rating (CDR) score ≥0.5 points, Hachinski Ischemic Score \\\u003C4 points\n3. Brain MRI showing bilateral temporal lobe and hippocampal atrophy\n4. Age ≥50 years\n\nInclusion criteria for control group:\n\n1. Healthy subjects with age matched to the AD group\n2. Normal cognitive function and good activities of daily living\n3. No dementia patients among first-degree relatives\n4. Negative brain MRI and neurological examination\n\nExclusion Criteria:\n\n1. Dementia or cognitive impairment caused by other diseases\n2. History of substance abuse\n3. Progressive primary aphasia\n4. Previous traumatic brain injury\n5. Patients with comorbid depression, schizophrenia, or severe diseases of the cardiovascular, hepatic, renal, or hematological systems\n6. Impaired consciousness and inability to cooperate\n7. Other conditions unsuitable for inclusion","50 Years",{"count":111,"type":22},40,"INTERVENTIONAL",[114],"NA","Alzheimer's disease is the most common memory loss disease among the elderly. This disease affects the patient's memory, language, attention, and behavioral abilities. Current research has found that in the early stages of the disease, synaptic connections between brain nerve cells become abnormal, but the specific cause is still unclear. Investigators' previous research discovered that in the brains of diseased mice, certain special substances (the miR 342 5p\u002FAnkG-mediated pathway) might be related to this abnormality, and these substances can be detected in both blood and cerebrospinal fluid. Therefore, investigators want to further explore the specific mechanisms of abnormal nerve cell connections, seek biomarkers for early detection of the disease, and provide new ideas for early diagnosis in the future.",[82,27],"2026-01-18",{"date":119,"type":37},"2026-01-20",{"date":121,"type":37},"2025-06-20",{"date":123,"type":22},"2026-03-10",{"name":125,"class":44},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine"]