[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00884455":3,"trial-entities:NCT00884455":70,"trial-summary:NCT00884455":74},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":34,"minimum_age":35,"maximum_age":36,"healthy_volunteers":37,"eligibility_criteria":38,"std_ages":43,"locations":47,"central_contacts":56,"overall_officials":57,"references":61,"see_also_links":69},"NCT00884455","IRB201500842 AATD Tissue Bank","Alpha-1 Foundation DNA and Tissue Bank","ENROLLING_BY_INVITATION","2033-06-10","2025-08","2026-01-15","2002-12","University of Florida","OTHER",false,"This is a long-term follow-up banking protocol that collects medical information and tissue (blood, liver and lung) samples for future research; use of data and samples for research purposes is overseen by the Tissue Bank Advisory Committee; the purpose of the Bank is to further research on alpha-1 antitrypsin deficiency.","Subject participation includes completion of informed consent, medical questionnaire, and email authorization. Subjects may provide a blood sample for alpha-1 antitrypsin genotype, phenotype and level. Lung and liver tissue may also be provided if available. Subjects may be contacted no more often than annually for updated information.\n\nThis project has a certificate of confidentiality from NIH.",[18],"Alpha 1 Antitrypsin Deficiency",[20],"tissue banking, research","OBSERVATIONAL",null,[],{"count":25,"type":26},5000,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Data and tissue samples","At the end of 15 years the tissue and data sample usage will be analyzed to determine continuation of the project. Each year the investigator provides a summary to the Alpha-1 Foundation.","The total number of tissue samples received and used for research are tracked annually.",[],"ALL","0 Years","100 Years",true,{"inclusion":39,"exclusion":41,"raw_text":42},[40],"all interested individuals may enroll",[],"Inclusion Criteria:\n\n* all interested individuals may enroll\n\nExclusion Criteria:\n\n* there are no exclusion criteria",[44,45,46],"CHILD","ADULT","OLDER_ADULT",[48],{"facility":12,"city":49,"state":50,"zip":51,"country":52,"geoPoint":53},"Gainesville","Florida","32610","United States",{"lat":54,"lon":55},29.65163,-82.32483,[],[58],{"name":59,"affiliation":12,"role":60},"Karina Serban, MD","PRINCIPAL_INVESTIGATOR",[62,66],{"pmid":63,"type":64,"citation":65},"20054436","RESULT","Tonelli AR, Rouhani F, Li N, Schreck P, Brantly ML. Alpha-1-antitrypsin augmentation therapy in deficient individuals enrolled in the Alpha-1 Foundation DNA and Tissue Bank. Int J Chron Obstruct Pulmon Dis. 2009;4:443-52. doi: 10.2147\u002Fcopd.s8577. Epub 2009 Dec 29.",{"pmid":67,"type":64,"citation":68},"22835581","Clark VC, Dhanasekaran R, Brantly M, Rouhani F, Schreck P, Nelson DR. Liver test results do not identify liver disease in adults with alpha(1)-antitrypsin deficiency. Clin Gastroenterol Hepatol. 2012 Nov;10(11):1278-83. doi: 10.1016\u002Fj.cgh.2012.07.007. Epub 2012 Jul 24.",[],{"nct_id":4,"conditions":71,"biomarkers":73},[72],"Alpha-1 Antitrypsin Deficiency",[],{"nct_id":4,"found":14,"summary":22,"prompt_version":22}]