[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT01656447":3,"trial-entities:NCT01656447":92,"trial-summary:NCT01656447":95},{"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":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":35,"sex":41,"minimum_age":42,"maximum_age":24,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":51,"locations":54,"central_contacts":75,"overall_officials":82,"references":87,"see_also_links":88},"NCT01656447","2014-276","Scleroderma Registry & Repository at the Hospital for Special Surgery","The Scleroderma Registry & Repository","RECRUITING","2030-01","2025-10","2025-11-26","2006-08","Hospital for Special Surgery, New York","OTHER",false,"The overall objective of the Scleroderma Registry is to support and promote the basic science and clinical research of this complex rheumatic disease at the Hospital for Special Surgery (HSS). The registry facilitates our understanding of the clinical features, pathobiology, genetics of Scleroderma. This will ultimately lead to a potential treatment for this currently untreatable condition.","What will be asked of you:\n\n* Completion of 2 health questionnaires\n* Donation of research bloods. This is optional, but encouraged (if possible).\n* We also encourage patients who come for initial visits to return so follow-up data can be collected.\n\nBenefits to Patients:\n\n* The HSS Scleroderma Registry gives patients the opportunity to participate in observational research with the goal of improving the lives of patients in the future.\n* By donating research bloods and providing clinical information, patients will help generate new knowledge about Scleroderma that can guide the treatment and care of patients afflicted with this rare disease.\n* Patients will also receive a comprehensive, medical evaluation from an HSS physician who specializes in treating Scleroderma. He or she will provide guidance on treatment options and recommendations for current or upcoming clinical trials.\n* Physicians will also make patients aware of the resources available to them, including support groups and educational programs.",[19],"Scleroderma",[19,21,22],"Scleroderma Registry","Hospital for Special Surgery Scleroderma","OBSERVATIONAL",null,[],{"count":27,"type":28},300,"ESTIMATED",[],[31],{"measure":32,"description":33,"timeFrame":34},"Modified Rodnan Skin Score","Physician score of skin thickening over 17 areas of the body.","Baseline & follow-up visits during regularly scheduled appointments for up to 5 years",[36,39],{"measure":37,"description":38,"timeFrame":34},"Scleroderma Health Assessment Questionnaire","Patient questionnaire",{"measure":40,"description":38,"timeFrame":34},"Short Form-36","ALL","18 Years",true,{"inclusion":45,"exclusion":47,"raw_text":50},[46],"Individuals older than 18 years of age with Scleroderma",[48,49],"Individuals younger than 18 years of age","Individuals older than 18 years of age without Scleroderma","Inclusion Criteria:\n\n* Individuals older than 18 years of age with Scleroderma\n\nExclusion Criteria:\n\n* Individuals younger than 18 years of age\n* Individuals older than 18 years of age without Scleroderma",[52,53],"ADULT","OLDER_ADULT",[55],{"facility":56,"status":8,"city":57,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":72},"Hospital for Special Surgery","New York","10021","United States",[61,66,69],{"name":62,"role":63,"phone":64,"email":65},"Eliza Pelrine, BA","CONTACT","212-774-2123","pelrinee@hss.edu",{"name":67,"role":68},"Robert Spiera, MD","PRINCIPAL_INVESTIGATOR",{"name":70,"role":71},"Jessica Gordon, MD","SUB_INVESTIGATOR",{"lat":73,"lon":74},40.71427,-74.00597,[76,78],{"name":62,"role":63,"phone":77,"email":65},"(212)774-2123",{"name":79,"role":63,"phone":80,"email":81},"Emily Bakaj, BA","(212)774-7620","bakaje@hss.edu",[83,85],{"name":84,"affiliation":13,"role":68},"Robert F Spiera, MD",{"name":86,"affiliation":13,"role":68},"Jessica K Gordon, MD",[],[89],{"label":90,"url":91},"Scleroderma, Vasculitis, \\& Myositis Center Website","http:\u002F\u002Fwww.hss.edu\u002Fscleroderma-vasculitis-center.asp",{"nct_id":4,"conditions":93,"biomarkers":94},[19],[],{"nct_id":4,"found":43,"summary":96,"prompt_version":106},{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an observational study, meaning researchers will collect information without giving any specific interventions. It plans to enroll 300 participants.","completed","Scleroderma Registry at Hospital for Special Surgery","This observational study, called the Scleroderma Registry, aims to better understand scleroderma, a complex rheumatic disease. Researchers are collecting information and optional blood samples from adults (18 years or older) who have scleroderma. The goal is to learn more about the disease's features, biology, and genetics, which could eventually lead to new treatments. You would complete two health questionnaires and may be asked to donate blood for research. The study will track changes in your skin thickness (Modified Rodnan Skin Score) during your regular doctor visits for up to five years. This research helps generate new knowledge to improve care for people with scleroderma.","Your skin thickness will be measured at baseline and follow-up visits during regularly scheduled appointments for up to 5 years.",104,"You would complete two health questionnaires and are encouraged to donate research blood. Follow-up data will be collected during your regular doctor visits.","Not stated in the trial record.",[],"v2"]