[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495980":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":107,"collaborators":10,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":10,"studyType":123,"phases":10,"briefSummary":124,"conditions":125,"keywords":10,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A",null,"We expect that some of the eligible patients (Group A) will undergo surgery without NACT. Group A will undergo only one preoperative study visit (baseline) within 45 days prior to their surgery. Group A will complete the study assessments and follow-ups. Some patients of Group A will undergo adjuvant chemotherapy after surgery; this will not affect their study timeline.",[13,14],"Diagnostic Test: Clinical Frailty Scale","Diagnostic Test: Frailty Phenotype",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B","Patients undergoing NACT before their surgery (group B) will have a first baseline study assessment within 45 days prior to their first chemotherapy treatment; in this group, a second preoperative study visit will be repeated after chemotherapy is considered terminated at least 18 days post-chemotherapy cycle and within 45 days prior to surgery. Group B will complete the study assessments and follow-ups. Some patients of Group B will undergo adjuvant chemotherapy after surgery; this will not affect their study timeline.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Group C","Post-chemotherapy, a small proportion of patients will not be deemed eligible for surgery by the treating physician (group C). Group C will be included in the evaluation of chemotherapy-related outcomes, and will also be asked to complete a follow-up visit 6 months from the date of registration",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Group D","An even smaller proportion of patients will initially be deemed eligible, recruited, and will complete the baseline assessment; however, they will eventually not undergo neither surgery nor chemotherapy. For Group D, a follow-up visit at 6 months from the baseline visit will be completed.",[13,14],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DIAGNOSTIC_TEST","Clinical Frailty Scale","A way to summarize the overall level of fitness or frailty of an older adult after they had been evaluated by an experienced clinician",[9,16,20,24],[34],"CFS",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Frailty Phenotype","Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity",[9,16,20,24],[40],"FP",[42],{"name":43,"affiliation":5,"role":44},"Maura Marcucci, MD","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Julie My Van Nguyen, MD","CONTACT","905-521-2100","nguyenjmv@HHSC.CA",{"name":52,"role":48,"phone":49,"phoneExt":10,"email":53},"Emily Di Sante, MA","emily.disante@phri.ca",[55,71,83,95],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Juravinksi Hospital","RECRUITING","Hamilton","Ontario","L8V 1C3","Canada","CA",{"type":64,"coordinates":65},"Point",[66,67],-79.84963,43.25011,{"lat":67,"lon":66},[70],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},{"facility":72,"status":57,"city":73,"state":59,"zip":74,"country":61,"countryCode":62,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Credit Valley Hospital","Mississauga","L5M 2N1",{"type":64,"coordinates":76},[77,78],-79.6583,43.5789,{"lat":78,"lon":77},[81],{"name":82,"role":48,"phone":10,"phoneExt":10,"email":10},"Tiffany Zigras, MD",{"facility":84,"status":57,"city":85,"state":59,"zip":86,"country":61,"countryCode":62,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Sunnybrook","Toronto","M4N 3M5",{"type":64,"coordinates":88},[89,90],-79.39864,43.70643,{"lat":90,"lon":89},[93],{"name":94,"role":48,"phone":10,"phoneExt":10,"email":10},"Danielle Vicus, MD",{"facility":96,"status":57,"city":85,"state":59,"zip":97,"country":61,"countryCode":62,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"University Health Network","M5G 2Z5",{"type":64,"coordinates":99},[89,90],{"lat":90,"lon":89},[102],{"name":103,"role":48,"phone":104,"phoneExt":105,"email":106},"Liat Hogen, MD","416-946-4501","5065","Liat.Hogen@uhn.ca",{"type":108,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100495980","frailty-assessments-for-risk-assessment-in-gynecologic-oncology-patients-100495980",false,"NCT05738252","Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients","Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients Undergoing Surgery and Chemotherapy","FARGO","Inclusion Criteria:\n\n1. Age must be 55 years or older at registration\n2. Must meet any one of the following criteria:\n\n   1. Have stage II-IV ovarian or endometrial cancer, undergoing cytoreductive surgery via laparotomy, with or without neoadjuvant chemotherapy (NACT)\n   2. Have any stage endometrial, uterine or cervical cancer planned for laparotomy where laparoscopy is deemed unfeasible\u002Fhigh-risk due to comorbidities\n   3. Are undergoing laparotomy for pelvic mass, highly suspicious for malignancy; or\n   4. Are undergoing laparotomy for gynecologic malignancy recurrence.\n\nExclusion Criteria:\n\n1. Unable to provide informed consent\n2. Require urgent surgery within 24 hours of first consultation to the Gynecological Oncology team\n3. Are undergoing neoadjuvant radiation therapy\n4. Have a previously documented history of dementia\n5. Have cognitive, language, vision, or hearing impairment that impacts ability to understand the directions for the completion of the study instruments\n6. Are participating in a clinical trial investigating a new systemic therapy","FEMALE","55 Years","110 Years",{"count":121,"type":122},280,"ESTIMATED","OBSERVATIONAL","FARGO is a prospective cohort study that aims to determine the performance of preoperative frailty assessment based on the Frailty Phenotype (FP), compared to a perioperative cardiovascular risk assessment based on the combination of preoperative Revised Cardiac Risk Index (RCRI), age and occurrence of myocardial injury after noncardiac surgery (MINS), in predicting the composite of all-cause death or new disability at 6 months after surgery in patients aged 55 or older. Patients will have confirmed or suspected gynecologic cancer, undergoing cytoreductive or high-risk surgery with or without chemotherapy.",[126,127,128],"Gynecologic Cancer","Frailty","Oncology","2025-04-12",{"date":131,"type":132},"2025-04-16","ACTUAL",{"date":134,"type":132},"2023-06-15",{"date":136,"type":122},"2025-10",{"name":5,"class":6},4]