[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05889806":3,"trial-entities:NCT05889806":72,"trial-summary:NCT05889806":84},{"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":28,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":30,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":55,"locations":58,"central_contacts":68,"overall_officials":69,"references":70,"see_also_links":71},"NCT05889806","US005","AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)","AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens Involved in Diseases and Healthy Populations)","ENROLLING_BY_INVITATION","2043-06-10","2023-06","2023-06-05","2023-05-10","Audubon Bioscience","INDUSTRY",false,"Study purpose: to explore the entire spectrum of proteomic and genomic changes (amongst others) involved in diseases and in healthy\u002Fcontrol populations. The Study is designed to discover biomarkers, develop and validate diagnostic assays, instruments and therapeutics as well as other medical research. Specifically, researchers may analyze proteins, RNA, DNA copy number changes, including large and small (1,000-100,000 kb) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both diseased tissue and case-matched germline DNA from Subjects.","The primary objective of this Study is to collect high-quality tissue, whole teeth, and biofluid Specimens, and associated Clinical Data from consented Subjects.\n\nThe secondary objective of this Study is to test Specimens and associated Clinical Data to confirm pathology diagnosis and correlation of microscopic evaluation with the provided information, to assess RNA and DNA integrity or degradation, and provide overall quality control evaluations.",[19,20,21,22,23,24,25,26,27],"Oncology","Hematologic Malignancy","Gastro-Intestinal Disorder","Autoimmune Diseases","Pregnancy Related","Infectious Disease","Cardiovascular Diseases","Genitourinary Disease","Renal Disease",[],"OBSERVATIONAL",null,[],{"count":33,"type":34},10000,"ESTIMATED",[36],{"type":37,"name":38,"description":38,"armGroupLabels":39},"OTHER","Observational Study Only. NO Intervention.",[40,41],"Healthy","Subjects with various conditions",[43],{"measure":44,"description":45,"timeFrame":46},"Enrollment and collection totals for a diverse population of subjects\u002Fconditions involved in diseases and in healthy\u002Fcontrol populations.","We will total the number of subjects and characterize the totals by disease state, gender, ethnicity and specimens contributed","Through study completion, an average of once per year",[],"ALL","18 Years",true,{"inclusion":52,"exclusion":53,"raw_text":54},[],[],"Inclusion Criteria:\n\n1. Subject shall be at least 18 years of age, or higher if required by Applicable Law.\n2. Subject's Clinical Data shall be relevant to the Study in which he\u002Fshe is participating.\n3. Subject shall understand and voluntarily sign the ICF prior to the Study participation. If the Subject is illiterate, the witness must sign the ICF (see 5.6. for details). If the Subject is incapable of consenting himself\u002Fherself, the legally authorized representative must sign the ICF (see 5.6. for details).\n4. Subject shall meet any other additional inclusion criteria specified in Appendices to this Protocol, or in additional written instructions of the Sponsor.\n5. Subject shall be able to donate the requested Specimen(s) without compromising his\u002Fher current health status.\n\nExclusion Criteria:\n\n1. Younger than 18 years of age, or higher if required by Applicable Law.\n2. The individual is incapable of understanding the items listed in the ICF and the consent process unless consented by the legally authorized representative.\n3. Prisoner",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"AUD","New Orleans","Louisiana","70112","United States",{"lat":66,"lon":67},29.95465,-90.07507,[],[],[],[],{"nct_id":4,"conditions":73,"biomarkers":83},[74,75,76,77,78,79,80,81,82],"Autoimmune Disease","Cardiovascular Disorder","Digestive System Disorder","Genitourinary System Disorder","Infectious Disorder","Malignant Neoplasm","Malignant neoplasm of lymphoid, hematopoietic and\u002For related tissue","Nephropathy","Pregnancy-Related Conditions",[],{"nct_id":4,"found":15,"summary":30,"prompt_version":30}]