[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04004286":3,"trial-entities:NCT04004286":95,"trial-summary:NCT04004286":98},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":52,"locations":55,"central_contacts":88,"overall_officials":91,"references":93,"see_also_links":94},"NCT04004286","900405","Defense and Veterans Center for Integrative Pain Management (DVCIPM) Pain Registry Biobank","Defense and Veterans Center for Integrative Pain Management (DVCIPM)Pain Registry Biobank","RECRUITING","2050-02","2026-01","2026-01-28","2019-02-01","Defense and Veterans Center for Integrative Pain Management","OTHER",false,"This Pain Registry Biobank is a prospective cohort design study whereby data (PASTOR survey, blood and saliva specimens, clinical data) is collected from participants in a longitudinal fashion with continual enrollment.","The Defense and Veterans Center for Integrative Pain Management (DVCIPM) established a clinical data registry and tissue biobank (pain registry\u002Fbiobank) for the advancement of pain-related research. This Pain Registry Biobank will address the complexity of pain by utilizing the Pain Assessment Screening Tool \\& Outcomes Registry (PASTOR), a thorough biopsychosocial assessment that extends beyond a single-item pain rating scale. PASTOR is an assessment battery that includes several Patient Reported Outcomes Measurement Information System (PROMIS) scales developed by the National Institutes of Health (NIH) and other important scales that span physical, psychological, social, and behavioral aspects of pain and pain-related treatments. As a uniform assessment system, PASTOR also mitigates a significant challenge in pain-related research, the lack of standardized, cross-study outcomes. Additionally, the richness of PASTOR data matched with biological samples allows future researchers to address significant research gaps and enhance health care for service members, veterans, and civilians.",[19],"Pain",[21],"Pain PASTOR Biobank","OBSERVATIONAL",null,[],{"count":26,"type":27},300,"ESTIMATED",[],[30,34,37],{"measure":31,"description":32,"timeFrame":33},"Pain Registry: PASTOR survey","a thorough biopsychosocial assessment computer adaptive screening tool that extends beyond a single-item pain rating scale. PASTOR is an assessment battery that includes several Patient Reported Outcomes Measurement Information System (PROMIS) scales developed by the National Institutes of Health (NIH) and other important scales that span physical, psychological, social, and behavioral aspects of pain and pain-related treatments.","Up to 30 years",{"measure":35,"description":36,"timeFrame":33},"Pain Registry: Blood specimens","43 ml of blood collected and processed for storage from EDTA, BDP 100, PAXgene RNA, and DNA blood collection tubes",{"measure":38,"description":39,"timeFrame":33},"Pain Registry: Saliva","up to 10ml of saliva, collected in 2ml cryovials.",[],"ALL","18 Years","80 Years",true,{"inclusion":46,"exclusion":49,"raw_text":51},[47,48],"Eligibile for care within the Military Healthcare System","Able and willing to provide written consent",[50],"Cannot understand English","Inclusion Criteria:\n\n* Eligibile for care within the Military Healthcare System\n* Able and willing to provide written consent\n\nExclusion Criteria:\n\n* Cannot understand English",[53,54],"ADULT","OLDER_ADULT",[56,73],{"facility":57,"status":8,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":70},"Naval Medical Center San Diego","San Diego","California","92134","United States",[63,67],{"name":64,"role":65,"phone":66},"Mary Jo Lindl, MS","CONTACT","619-385-3569",{"name":68,"role":69},"Eugenio Lujan, MD","PRINCIPAL_INVESTIGATOR",{"lat":71,"lon":72},32.71571,-117.16472,{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":61,"contacts":78,"geoPoint":85},"Walter Reed National Military Medical Center","Bethesda","Maryland","20889",[79,83],{"name":80,"role":65,"phone":81,"email":82},"Mary E McDuffie, RN BSN","301\u002F400\u002F4242","mary.mcduffie.ctr@usuhs.edu",{"name":84,"role":69},"Harold J Gelfand, MD",{"lat":86,"lon":87},38.98067,-77.10026,[89],{"name":90,"role":65,"phone":81,"email":82},"Mary E McDuffie, RN,BSN",[92],{"name":84,"affiliation":13,"role":69},[],[],{"nct_id":4,"conditions":96,"biomarkers":97},[19],[],{"nct_id":4,"found":44,"summary":99,"prompt_version":108},{"design":100,"status":101,"heading":6,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study with a planned enrollment of 300 participants. It is designed as a prospective cohort study, meaning data is collected over time from a group of people.","completed","This study is creating a Pain Registry Biobank to better understand pain. It's collecting information and samples from people with pain over a long period. Researchers will use surveys (like the PASTOR survey, which asks about physical, mental, and social aspects of pain) and biological samples (blood and saliva) to learn more about pain and how to treat it. The goal is to improve care for service members, veterans, and civilians. You might be able to join if you are between 18 and 80 years old, are eligible for care within the Military Healthcare System, and can understand English and provide written consent. This is an observational study, meaning researchers are collecting information without testing a specific treatment. The study is currently enrolling participants.","Participants will be followed for up to 30 years, with data and sample collection occurring throughout this period.",124,"You would provide survey responses (PASTOR survey), blood samples, and saliva samples. This data collection will occur over a period of up to 30 years.","Not stated in the trial record.",[],"v2"]