[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"next-generation-sequencing-ngs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:next-generation-sequencing-ngs":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,74,97,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100628176","phase-3-efficacy-of-integrating-next-generation-sequencing-for-treatment-of-surgical-site-infection-after-fracture-fixation-100628176",false,"NCT07458230","Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:","Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation: A Multicenter Randomized Control Trial","NGS","Inclusion Criteria:\n\n* Age 18-84 years\n* History of extremity fracture proximal to the metatarsals and carpal bones treated with any type of internal fixation. Note that both healed and unhealed fractures are eligible.\n* Deep infection requiring surgery after fracture fixation as determined by either of the following:\n\nFRI confirmatory criteria CDC criteria (without the timeframe). This includes the possibility of culture negative infection but determined to be infection by treatment team.\n\n* Plan for treatment includes antibiotic therapy prescribed by Infectious Disease provider(s), regardless of SOCHB culture or NGS results.\n\nExclusion Criteria:\n\n* Spine fractures\n* High risk of amputation based on the initial managing physician opinion\n* Incarcerated\u002Finstitutionalized\n* Patient is too sick to have surgery, i.e., medical co-morbidities which preclude treatment with a general anesthetic\n* Prior history of chronic infection at the surgical site\n* Pathological fractures from a neoplastic process\n* History of Paget's Disease\n* Unavailable for the planned 12 months of follow-up (e.g., planned follow-up at a location other than one of the study sites)\n* Extremity fracture occurred more than 2 years prior to the hospital admission for the presenting infection","ALL","18 Years","84 Years",{"count":21,"type":22},250,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study focuses on the serious problem of infections and wound-healing issues that can happen after high-energy bone fractures. These complications are common and can affect between 10% and 60% of patients, especially those with severe injuries. When a fracture is repaired with surgery and an infection develops afterward, patients often face long recovery times, more pain, and sometimes multiple surgeries. In the worst cases, the infection can lead to permanent disability or even amputation. The current standard test used in hospitals, called a culture, often misses certain bacteria, which can make treatment less effective. Because of this, the study aims to find out whether adding a newer test called Next Generation Sequencing (NGS) can help doctors identify infections more accurately and improve patient outcomes.\n\nThe main goal of the study is to see whether using NGS along with standard hospital cultures reduces the number of treatment failures compared to using standard cultures alone. Treatment failure means the infection does not get better and the patient must return to the operating room. The study also wants to learn whether NGS helps doctors make better antibiotic choices and avoid unnecessary or ineffective treatments. Another goal is to understand which NGS results are most helpful when doctors decide to change a patient's antibiotics. By learning this, researchers hope to create a model that explains how NGS information influences treatment decisions.\n\nTo join the study, patients must be between 18 and 84 years old and have a deep infection after a fracture was repaired with internal fixation, such as plates, screws, or rods. Patients must also meet infection criteria from either the Fracture-Related Infection (FRI) guidelines or the CDC's infection criteria. A total of 250 patients will be randomly placed into one of two groups: one group will receive treatment guided by both NGS and standard cultures, while the other group will receive treatment based only on standard cultures. Researchers will then compare how often treatment fails in each group.\n\nTreatment failure includes several possible outcomes. The most important is an unplanned return to the operating room because the infection did not improve. Other types of failure include new superficial infections that do not require surgery, bones that fail to heal properly (called nonunion), amputation, and complications caused by antibiotics. Patients will return for follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after joining the study so researchers can track the patient's progress and monitor for any problems.\n\nRight now, the failure rate for treating these infections using standard hospital cultures is about 30%, which is considered unacceptably high. The researchers believe that adding NGS will help lower this number because NGS can detect more types of bacteria, including ones that are hard to grow in a lab. With better information, doctors can choose antibiotics that are more likely to work the first time, which may reduce the need for additional surgeries and improve healing. This could be especially important for military service members, who often suffer high-energy injuries and face a greater risk of long-term complications if treatment fails.\n\nNGS is already available, covered by Medicare, and fast enough to be useful in real-time medical decisions. If this study shows that NGS improves treatment outcomes, hospitals could begin using it widely and quickly. The researchers hope that this approach will lead to fewer infections, better antibiotic use, faster recovery, and improved long-term function for patients.",[28,29,30],"Next Generation Sequencing (NGS)","Surgical Site Infection (SSI)","Fracture Fixation",[28],"NOT_YET_RECRUITING","2026-05-07",{"date":35,"type":36},"2026-05-08","ACTUAL",{"date":38,"type":22},"2026-07-01",{"date":40,"type":22},"2028-10-01",{"name":42,"class":43},"Johns Hopkins Bloomberg School of Public Health","OTHER",18,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100583728","study-of-congenital-orofacial-clefts-by-implementing-optical-genome-mapping-100583728","NCT06880094","Study of Congenital Orofacial Clefts by Implementing Optical Genome Mapping","CARTOFENTE","Inclusion Criteria:\n\n* Individuals with syndromic, complex or familial oral-facial clefts\n* With no established genetic diagnosis\n* Followed up at the Amiens-Picardie University Hospital\n\nExclusion Criteria:\n\n* genetic diagnosis of oral-facial cleft\n* No health insurance affiliation\n* Patient under guardianship or curatorship, under safeguard of justice or deprived under public law\n* Pregnant, parturient or breast-feeding woman",{"count":53,"type":22},26,[55],"NA","Orofacial clefts, the most common congenital craniofacial malformations, have a complex etiology involving an interaction between genetic and environmental factors.\n\nChromosomal abnormalities, including structural variations, represent a major cause of human pathology. Recently, technological developments and the introduction of next-generation sequencing (NGS) technologies have revolutionized the field of medical genetics.\n\nOptical genome mapping (OGM) is an innovative, high-resolution \"long read\" technique that enables the identification of all classes of chromosomal variation, consisting in the direct visualization of long, labeled DNA molecules throughout the genome. This technology is gradually becoming an essential tool for studying onco-hematology and constitutional genetic pathologies The purpose of this study is to search for structural chromosomal variants (SV) or copy number variants (CNV) not identifiable either by cytogenetic methods nor by \"short read\" NGS \"short read, in individuals with oral-facial clefts with no genetic diagnosis.",[58,28,59],"Orofacial Clefts","Optical Genome Mapping",[61,62,59],"orofacial clefts","Next Generation Sequencing","RECRUITING","2026-01-15",{"date":66,"type":36},"2026-01-16",{"date":68,"type":36},"2025-02-18",{"date":70,"type":22},"2027-04",{"name":72,"class":43},"Centre Hospitalier Universitaire, Amiens",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":73},"100614309","reflectance-confocal-microscopy-and-molecular-correlation-in-atypical-melanocytic-lesions-100614309","NCT07277920","Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions","Evaluation of Reflectance Confocal Microscopy (RCM) Features in Surgically Excised Atypical Melanocytic Lesions and Their Correlation With Next-Generation Sequencing (NGS) Patterns","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presence of cutaneous lesions with dermoscopic and reflectance confocal microscopy suspicion of melanocytic neoplasia, already scheduled for surgical excision\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Lesions not scheduled for excision or with uncertain dermoscopic diagnosis\n* Lack of informed consent",{"count":82,"type":22},200,"OBSERVATIONAL","This observational, prospective cohort study aims to evaluate the diagnostic relevance of Reflectance Confocal Microscopy (RCM) features in atypical melanocytic lesions scheduled for surgical excision, and to correlate these imaging features with molecular profiles obtained through Next-Generation Sequencing (NGS). Approximately 200 consecutive lesions, including atypical nevi and early-stage melanomas, will be analyzed from patients attending the Videomicroscopy and Confocal Clinic at the Dermatology Department of the University Hospital of Modena.\n\nThe primary objective is to assess the diagnostic significance of RCM features-specifically atypical cells and disarrangement of the dermoepidermal junction (DEJ)-for early detection of melanoma. Secondary objectives include correlating RCM morphological patterns with NGS-derived genetic alterations and identifying molecular signatures that differentiate early-stage melanomas from benign nevi.\n\nAll procedures are performed as part of routine clinical care, including dermoscopic and confocal evaluation, surgical excision, histopathology, and molecular analysis on formalin-fixed, paraffin-embedded blocks. Data will be anonymized, securely stored, and analyzed to determine associations between imaging and genetic variables. This study integrates morphological and molecular data to refine diagnostic workflows and improve early melanoma detection.",[86,87,28],"Melanocytic Nevi","Melanoma (Skin Cancer)","2025-11-29",{"date":90,"type":36},"2025-12-11",{"date":92,"type":36},"2023-11-01",{"date":94,"type":22},"2026-12-31",{"name":96,"class":43},"University of Modena and Reggio Emilia",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":103,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100574747","ngs-mrd-guided-blinatumomab-treatment-for-pediatric-b-all-100574747","NCT06763302","NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL","Inclusion Criteria:\n\n* Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).\n* Age ≥1 year and \\\u003C18 years.\n* Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.\n\nExclusion Criteria:\n\n* Age \\\u003C1 year or ≥18 years.\n* Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.\n* Secondary leukemia or second tumor, CML blast phase ALL.\n* Other tumors or immunodeficiency diseases present.","1 Year",{"count":105,"type":22},1220,[55],"The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment.\n\nThe main questions it aims to answer are:\n\n1. Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy?\n2. Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?",[109,110,111,28],"B Cell Precursor Acute Lymphoblastic Leukemia","Pediatric","Minimal Residual Disease","2025-01-02",{"date":114,"type":36},"2025-01-08",{"date":116,"type":22},"2025-01-01",{"date":118,"type":22},"2030-12-31",{"name":120,"class":43},"The Children's Hospital of Zhejiang University School of Medicine",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":128,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":73},"100410586","research-on-the-heterogeneity-of-taiwanese-breast-cancer-patients-by-next-generation-sequencing-ngs-tools-100410586","NCT04626440","Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools","Comprehensive Precision Medicine Research on the Heterogeneity of Taiwanese Breast Cancer Patients by Next Generation Sequencing (NGS) Tools","Inclusion Criteria:\n\n* Female subjects aged over 20 years old\n* Subject with confirmed diagnosis of primary invasive breast cancer and is planning to receive treatments for breast cancer. However, subjects with breast cancer recurrence at screening will be enrolled if meet both the following conditions:\n\n  1. Subjects had received surgery for primary breast cancer within 3 years prior to screening \\[i.e. recurrence within 3 years after surgery (mastectomy or BCS)\\];\n  2. Subjects diagnosed with stage IV breast cancer beyond 3 years after surgery (mastectomy or BCS) or who had received or are currently receiving treatments for breast cancer. And subjects with primary tumor FFPE tissues available and pass the RNA quality check.\n* Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 3\n* Life expectancy ≥ 3 months\n* Subject agrees to provide the written informed consent. If a subject has breast cancer recurrence within 3 years prior to screening, she will be eligible if she agrees to provide the paired FFPE tissues (primary and recurrent tumors)\n\nExclusion Criteria:\n\n* Subjects will be excluded if they had primary cancer other than breast cancer within 5 years prior to screening","FEMALE","20 Years",{"count":131,"type":22},1875,"The objectives of this study are:\n\n1. To determine the difference in genetic profiling of subjects with breast cancer recurrence\n2. To determine the comprehensive genetic profiling of subjects with late stage breast cancer\n3. To determine the potential biomarkers for early detection and prognosis for breast cancer\n4. To determine the genetic profiling of immune system in different subtypes of breast cancer\n\nBy integrating and analyzing the data generated using the methods of NGS, these information can be used for:\n\n1. Understanding the genetic profiling of different subtypes of breast cancer in Taiwan\n2. Assessing the efficacy of different treatments in breast cancer subjects\n3. Defining the molecular risk factors and predicting the potential risk of breast cancer recurrence\n4. Assessing the immune repertoire and the potential effects of immunotherapy in breast cancer subjects\n5. Developing new strategies in treating patients with triple negative or late stage of breast cancer",[28,134],"Breast Cancer","2020-11-06",{"date":137,"type":36},"2020-11-12",{"date":139,"type":36},"2018-11-22",{"date":141,"type":22},"2026-08-31",{"name":143,"class":144},"vghtpe user","OTHER_GOV"]