[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05016908":3,"trial-entities:NCT05016908":84,"trial-summary:NCT05016908":88},{"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":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":26,"secondary_outcomes":31,"sex":32,"minimum_age":33,"maximum_age":16,"healthy_volunteers":16,"eligibility_criteria":34,"std_ages":44,"locations":48,"central_contacts":71,"overall_officials":73,"references":75,"see_also_links":83},"NCT05016908","2019P001504","Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy","RECRUITING","2027-11","2025-10","2025-11-24","2019-11-30","Massachusetts General Hospital","OTHER",false,"Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample.",null,[18],"Duchenne Muscular Dystrophy",[],"OBSERVATIONAL",[],{"count":23,"type":24},100,"ESTIMATED",[],[27],{"measure":28,"description":29,"timeFrame":30},"Extracellular RNA in biofluids","The extracellular RNA biomarkers in the muscular dystrophy groups will be evaluated and compared with the extracellular RNA content in control groups. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers as measurements of disease activity and severity.","4 years",[],"ALL","5 Years",{"inclusion":35,"exclusion":39,"raw_text":43},[36,37,38],"Subjects with DMD or BMD based on genetic testing. Control subjects are unknown to have any other muscular dystrophy by history and may have had no genetic testing.","Able to provide informed consent or assent for participation in the study.","Demographic characteristics for biofluid collection: Males age 5 years and older with DMD or BMD; males and females ages 18 years and older without muscular dystrophy.",[40,41,42],"Medical history of any of the following: State of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and\u002For C positive.","Use of anti-platelet drugs within 7 days prior to blood draw; use of anticoagulants within 60 days prior to blood draw.","Inability or unwillingness of the subject to give written informed consent.","Inclusion Criteria:\n\n* Subjects with DMD or BMD based on genetic testing. Control subjects are unknown to have any other muscular dystrophy by history and may have had no genetic testing.\n* Able to provide informed consent or assent for participation in the study.\n* Demographic characteristics for biofluid collection: Males age 5 years and older with DMD or BMD; males and females ages 18 years and older without muscular dystrophy.\n\nExclusion Criteria:\n\n* Medical history of any of the following: State of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and\u002For C positive.\n* Use of anti-platelet drugs within 7 days prior to blood draw; use of anticoagulants within 60 days prior to blood draw.\n* Inability or unwillingness of the subject to give written informed consent.",[45,46,47],"CHILD","ADULT","OLDER_ADULT",[49,59],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"geoPoint":56},"Boston Children's Hospital","ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02115","United States",{"lat":57,"lon":58},42.35843,-71.05977,{"facility":12,"status":7,"city":52,"state":53,"zip":60,"country":55,"contacts":61,"geoPoint":70},"02129",[62,67],{"name":63,"role":64,"phone":65,"email":66},"Tamkin Shahraki, MD","CONTACT","617-726-7506","tshahraki@mgh.harvard.edu",{"name":68,"role":69},"Thurman M. Wheeler, MD","PRINCIPAL_INVESTIGATOR",{"lat":57,"lon":58},[72],{"name":63,"role":64,"phone":65,"email":66},[74],{"name":68,"affiliation":12,"role":69},[76,80],{"pmid":77,"type":78,"citation":79},"30254196","BACKGROUND","Antoury L, Hu N, Balaj L, Das S, Georghiou S, Darras B, Clark T, Breakefield XO, Wheeler TM. Analysis of extracellular mRNA in human urine reveals splice variant biomarkers of muscular dystrophies. Nat Commun. 2018 Sep 25;9(1):3906. doi: 10.1038\u002Fs41467-018-06206-0.",{"pmid":81,"type":78,"citation":82},"31211175","Antoury L, Hu N, Darras B, Wheeler TM. Urine mRNA to identify a novel pseudoexon causing dystrophinopathy. Ann Clin Transl Neurol. 2019 May 17;6(6):1106-1112. doi: 10.1002\u002Facn3.777. eCollection 2019 Jun.",[],{"nct_id":4,"conditions":85,"biomarkers":87},[86,18],"Becker's Muscular Dystrophy",[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an observational study aiming to enroll 100 participants. It is not testing a specific drug or intervention.","completed","Observational Study of Extracellular RNA Biomarkers in Duchenne Muscular Dystrophy","This study is looking for less invasive ways to understand Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (BMD) activity, instead of muscle biopsies. Researchers want to see if they can detect and measure the severity of these conditions by looking at substances called extracellular RNA in your urine and blood samples. They will measure these substances over 4 years. You may be able to join if you are male and at least 5 years old with DMD or BMD confirmed by genetic testing. Control subjects (people without muscular dystrophy) are also needed. The study is currently unclear on its recruitment status and aims to enroll 100 participants.","Participants will have their extracellular RNA measured at 4 years.",108,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]