[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06966050":3,"trial-entities:NCT06966050":84,"trial-summary:NCT06966050":89},{"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":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":21,"healthy_volunteers":21,"eligibility_criteria":41,"std_ages":50,"locations":53,"central_contacts":75,"overall_officials":78,"references":80,"see_also_links":81},"NCT06966050","2025-0415","Multi-center MRD Registry for Inflammatory Breast Cancer","RECRUITING","2032-05-31","2026-05","2026-05-20","2025-05-05","M.D. Anderson Cancer Center","OTHER",false,"To collect data from participants with IBC who may have had MRD testing and may have surgery in the future.","Primary Objectives\n\n-To determine the incidence of protocol specified pre-surgery MRD-positivity in IBC (assessment between completion of planned systemic therapy and surgery).\n\nSecondary Objectives\n\n* To establish the feasibility of multi-institutional MRD data collection using standard of care Signatera analysis in IBC participants.\n* To evaluate the association of pre-surgery MRD to pathologic response.\n* To evaluate participant reported QOL for worry about recurrence based in participants receiving MRD results\n* To establish protocol-optional baseline and longitudinal MRD data collection in IBC participants and report the frequency of MRD longitudinally\n* To determine the median lead time between the first MRD-positive result and clinical recurrence.\n* To determine whether adjuvant therapies decrease the amount of MRD in participants, and the association with relapse.",[18],"Breast Cancer",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},200,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"BEHAVIORAL","Quality-of-life Questionnaire","Participants will be asked to fill out a quality-of-life questionnaire, which will take about 10-15 minutes to complete.",[32],"Group 1",[34],{"measure":35,"description":36,"timeFrame":37},"European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire","European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)\n\nScore scale: (1-30 questions to assess the impact of participants quality of life)","Through study completion; an average of 1 year",[],"ALL","18 Years",{"inclusion":42,"exclusion":48,"raw_text":49},[43,44,45,46,47],"Female or males ≥18 years of age with the ability to understand and sign a written","Participants who have a clinical diagnosis of stage III or IV inflammatory breast cancer (IBC).","Participants who are planning to have or already completed a minimum of one blood draw for Signatera testing, for which the result and clinical data can be deposited into the study database.","Participants must be within eight months of diagnosis and have not undergone breast surgery for this diagnosis of breast cancer.","Participants must be English-speaking.",[],"Inclusion Criteria:\n\n* Female or males ≥18 years of age with the ability to understand and sign a written\n* Participants who have a clinical diagnosis of stage III or IV inflammatory breast cancer (IBC).\n* Participants who are planning to have or already completed a minimum of one blood draw for Signatera testing, for which the result and clinical data can be deposited into the study database.\n* Participants must be within eight months of diagnosis and have not undergone breast surgery for this diagnosis of breast cancer.\n* Participants must be English-speaking.\n\nExclusion Criteria:\n\n\\-",[51,52],"ADULT","OLDER_ADULT",[54],{"facility":55,"status":7,"city":56,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":72},"MD Anderson Cancer Center","Houston","Texas","77030","United States",[61,66,70],{"name":62,"role":63,"phone":64,"email":65},"Sadia Saleem, MD","CONTACT","281-566-1900","ssaleem@mdanderson.org",{"name":67,"role":63,"phone":68,"email":69},"Angela Alexander","713-792-9137","aalexand@mdanderson.org",{"name":62,"role":71},"PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},29.76328,-95.36327,[76,77],{"name":62,"role":63,"phone":64,"email":65},{"name":67,"role":63,"phone":68,"email":69},[79],{"name":62,"affiliation":12,"role":71},[],[82],{"label":55,"url":83},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":85,"biomarkers":87},[86],"Breast Inflammatory Carcinoma",[88],"Circulating Tumor-Derived DNA Negative",{"nct_id":4,"found":90,"summary":91,"prompt_version":101},true,{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an observational study aiming to enroll 200 participants. It is not testing a new treatment but rather collecting information about existing care.","completed","Observational Study for Inflammatory Breast Cancer and MRD Testing","This study is collecting information from people with stage III or IV inflammatory breast cancer (IBC). It's looking at how often a specific blood test, called Signatera, shows signs of minimal residual disease (MRD) before surgery. MRD means there are still a few cancer cells left after treatment. You can join if you are 18 or older, have IBC, and have had or plan to have Signatera testing. The study also wants to understand how your quality of life is affected, especially your worries about cancer coming back, if you receive MRD test results. Researchers will follow participants for about one year to see how MRD results relate to treatment and if the cancer returns. The current recruitment status is unclear.","Your quality of life will be measured through study completion, which is an average of one year.",121,"You will be asked to complete a quality-of-life questionnaire, which takes about 10-15 minutes. The study will also collect information from your Signatera blood test results and other clinical data.","Not stated in the trial record.",[],"v2"]