[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06295965":3,"trial-entities:NCT06295965":93,"trial-summary:NCT06295965":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":29,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":33,"interventions":36,"primary_outcomes":42,"secondary_outcomes":52,"sex":53,"minimum_age":31,"maximum_age":31,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":64,"locations":68,"central_contacts":87,"overall_officials":89,"references":91,"see_also_links":92},"NCT06295965","RG1123813","Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study","Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers (CHANCES)","RECRUITING","2031-12-31","2026-04","2026-04-17","2024-01-02","University of Washington","OTHER",false,"This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is\u002Fare a genetic\u002Fenvironmental component(s) to developing blood cancer.","OUTLINE: This is an observational study.\n\nPatients undergo blood sample collection and complete surveys on study. Patients' medical records are also reviewed.",[19,20,21,22,23,24,25,26,27,28],"Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Recurrent Malignant Solid Neoplasm","Clonal Cytopenia of Undetermined Significance","Clonal Hematopoiesis","Idiopathic Cytopenia of Undetermined Significance","Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder","Ovarian Carcinoma","Myeloid Neoplasm Post Cytotoxic Therapy",[],"OBSERVATIONAL",null,[],{"count":34,"type":35},2000,"ESTIMATED",[37],{"type":14,"name":38,"description":39,"armGroupLabels":40},"Non-Interventional Study","Non-interventional study",[41],"Observational",[43,46,49],{"measure":44,"timeFrame":45},"Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients","Through study completion, up to 5 years",{"measure":47,"description":48,"timeFrame":45},"Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors","Measurement Tool: will measure by BM biopsy confirmation done by local hematologist",{"measure":50,"description":51,"timeFrame":45},"Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN","Measurement Tool: the variant allele fraction of the blood clone",[],"ALL",{"inclusion":55,"exclusion":61,"raw_text":63},[56,57,58,59,60],"Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:","Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy","Subjects who have or have had a solid tumor diagnosis and any of the following:","At least 4 months of exposure to a PARP inhibitor","Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm",[62],"Individuals with a life expectancy of less than 6 months","Inclusion Criteria:\n\n* Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:\n\n  * Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy\n\nOR\n\n* Subjects who have or have had a solid tumor diagnosis and any of the following:\n\n  * At least 4 months of exposure to a PARP inhibitor\n  * Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm\n\nExclusion Criteria:\n\n* Individuals with a life expectancy of less than 6 months",[65,66,67],"CHILD","ADULT","OLDER_ADULT",[69],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"Fred Hutch\u002FUniversity of Washington Cancer Consortium","Seattle","Washington","98109","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Swisher Lab Research Coordinators","CONTACT","206-616-8927","swisherlabrc@uw.edu",{"name":82,"role":83},"Elizabeth Swisher","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},47.60621,-122.33207,[88],{"name":77,"role":78,"phone":79,"email":80},[90],{"name":82,"affiliation":70,"role":83},[],[],{"nct_id":4,"conditions":94,"biomarkers":97},[24,95,27,96],"Myeloid Neoplasm","Solid Neoplasm",[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study involving 2000 participants. It means researchers will watch and collect information without giving you a specific treatment.","completed","CHANCES Study: Understanding Blood Changes in Cancer Patients","This study, called CHANCES, is looking at how certain changes in your blood, called clonal hematopoiesis (CH), and new blood cancers (therapy-emergent myeloid neoplasms or TMN) might develop in people with ovarian, fallopian tube, peritoneal, or other solid cancers. Researchers want to understand why these blood changes happen, especially in patients who have received platinum-based chemotherapy or PARP inhibitors. They are trying to find out if there are specific risk factors or genetic reasons for developing these conditions. You might be able to join if you have or had one of these cancers and have received or will receive at least 5 cycles of platinum-based chemotherapy, or if you've been exposed to a PARP inhibitor for at least 4 months. The study aims to track these changes for up to 5 years.","Participants will be followed through study completion, which could be up to 5 years.",132,"You would provide blood samples and complete surveys. Your medical records will also be reviewed.","Not stated in the trial record.",[],"v2"]