[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07731880":3,"trial-entities:NCT07731880":101,"trial-summary:NCT07731880":105},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":34,"sex":56,"minimum_age":57,"maximum_age":23,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":74,"locations":77,"central_contacts":95,"overall_officials":97,"references":99,"see_also_links":100},"NCT07731880","RG1126428","Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers","NOT_YET_RECRUITING","2029-07","2026-07","2026-07-28","2026-09","Fred Hutchinson Cancer Center","OTHER",false,"This study is being done to determine how easy it is to use standard of care (SOC) surgical resections or biopsy for SmartMatch analysis to determine treatment options in advanced gynecological malignancies.","OUTLINE: This is an observational study.\n\nPatients undergo tissue sample collection obtained from standard of care surgical resection or biopsy for SmartMatch laboratory analysis and have their medical records reviewed on study.",[18,19,20],"Malignant Female Reproductive System Neoplasm","Metastatic Malignant Female Reproductive System Neoplasm","Unresectable Malignant Female Reproductive System Neoplasm",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},30,"ESTIMATED",[],[30],{"measure":31,"description":32,"timeFrame":33},"Proportion of participants for whom SmartMatch generates at least one actionable treatment recommendation that is presented at the PMTB within 4 weeks (≤ 28 days) of fresh tissue acquisition","An actionable recommendation is defined as:\n\n1. FDA-approved therapy for any indication or available clinical trial;\n2. Predicted to have activity by SmartMatch functional precision medicine (FPM) and\u002For genomics;\n3. Endorsed by PMTB as clinically reasonable.","From enrollment up to 36 months",[35,38,40,42,45,47,49,51,53],{"measure":36,"timeFrame":37},"Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained","Up to 36 months",{"measure":39,"timeFrame":37},"Implementation Feasibility: Time from PMTB recommendation to first dose of matched therapy",{"measure":41,"timeFrame":37},"Implementation Feasibility: Time from live tissue collection to SmartMatch report",{"measure":43,"description":44,"timeFrame":37},"Implementation Feasibility: Reasons for access failure\u002Fdelay (insurance denial, clinical decline, etc.)","Will document reasons for failure or delay (insurance denial, lack of trial access, toxicity concerns, clinical deterioration, patient preference)",{"measure":46,"timeFrame":37},"Proportion of patients achieving growth modulation index (GMI) ≥ 1.3",{"measure":48,"timeFrame":37},"Proportion of patients achieving progression-free survival on matched therapy (PFSmatched)",{"measure":50,"timeFrame":37},"Proportion of patients achieving progression-free survival on the prior line of therapy (PFSpast)",{"measure":52,"timeFrame":37},"Proportion of patients achieving GMI = PFSmatched \u002F PFSpast",{"measure":54,"description":55,"timeFrame":37},"Proportion of patients who begin identified treatment pathways following Precision Medicine Tumor Board (PMTB) review","Proportion of patients falling into each pathway:\n\n* Genomic-matched therapy implemented\n* Functional\u002Forganoid-matched therapy implemented\n* Physician's choice therapy (no matched therapy recommended, not obtainable, or declined)","FEMALE","18 Years",{"inclusion":59,"exclusion":68,"raw_text":73},[60,61,62,63,64,65,66,67],"Age ≥ 18 years","Histologically confirmed rare gynecologic malignancy, including but not limited to those listed","Metastatic or unresectable disease, OR disease for which additional systemic therapy is indicated","Fresh tumor tissue available from a SOC surgical procedure or biopsy that in the judgment of the treating team will yield adequate viable tumor for SmartMatch analysis","Eastern Cooperative Oncology Group (ECOG) performance status 0-2","Adequate organ function to receive systemic therapy as determined by the treating oncologist (protocol does not specify thresholds because therapy is not mandated)","Ability to understand and willingness to sign informed consent","Willingness to allow data abstraction from the electronic health record for study endpoints",[69,70,71,72],"Lack of tumor tissue suitable for SmartMatch analysis","Purely borderline tumors or benign ovarian\u002Futerine neoplasms","Any condition that, in the opinion of the treating oncologist or PI, would interfere with receiving systemic therapy","Inability to provide informed consent or comply with study procedures","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed rare gynecologic malignancy, including but not limited to those listed\n* Metastatic or unresectable disease, OR disease for which additional systemic therapy is indicated\n* Fresh tumor tissue available from a SOC surgical procedure or biopsy that in the judgment of the treating team will yield adequate viable tumor for SmartMatch analysis\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Adequate organ function to receive systemic therapy as determined by the treating oncologist (protocol does not specify thresholds because therapy is not mandated)\n* Ability to understand and willingness to sign informed consent\n* Willingness to allow data abstraction from the electronic health record for study endpoints\n\nExclusion Criteria:\n\n* Lack of tumor tissue suitable for SmartMatch analysis\n* Purely borderline tumors or benign ovarian\u002Futerine neoplasms\n* Any condition that, in the opinion of the treating oncologist or PI, would interfere with receiving systemic therapy\n* Inability to provide informed consent or comply with study procedures",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":92},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Kalyan Banda, MD","CONTACT","206-606-2222","bkalyan@uw.edu",{"name":86,"role":91},"PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},47.60621,-122.33207,[96],{"name":86,"role":87,"phone":88,"email":89},[98],{"name":86,"affiliation":79,"role":91},[],[],{"nct_id":4,"conditions":102,"biomarkers":104},[103,18],"Female Reproductive System Neoplasm",[],{"nct_id":4,"found":106,"summary":107,"prompt_version":117},true,{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an observational study with a planned enrollment of 30 participants. It is not a drug trial.","completed","NOORI Study: SmartMatch for Rare Gynecologic Cancers","This study, called NOORI, is looking at how easy it is to use a special analysis called SmartMatch to help find treatment options for advanced rare gynecologic cancers. These are cancers of the female reproductive system that have spread (metastatic) or cannot be removed by surgery (unresectable). Researchers want to see if they can get enough fresh tumor tissue from standard surgeries or biopsies to use SmartMatch. The main goal is to see how many participants get at least one treatment recommendation from SmartMatch within 4 weeks of their tissue being collected. This study is for women aged 18 and older who have a confirmed rare gynecologic cancer that is metastatic, unresectable, or needs more treatment. The study is currently observational, meaning you would have your medical records reviewed and tissue samples collected as part of your regular care.","Participants will be followed for up to 36 months from enrollment.",139,"You would have tissue samples collected from a standard surgery or biopsy, and your medical records would be reviewed.","Not stated in the trial record.",[],"v2"]