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Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

Recruitingn/aAges 55 Years - 110 YearsFemalePopulation Health Research Institute
NCT05738252 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age must be 55 years or older at registration 2. Must meet any one of the following criteria: 1. Have stage II-IV ovarian or endometrial cancer, undergoing cytoreductive surgery via laparotomy, with or without neoadjuvant chemotherapy (NACT) 2. Have any stage endometrial, uterine or cervical cancer planned for laparotomy where laparoscopy is deemed unfeasible/high-risk due to comorbidities 3. Are undergoing laparotomy for pelvic mass, highly suspicious for malignancy; or 4. Are undergoing laparotomy for gynecologic malignancy recurrence. Exclusion Criteria: 1. Unable to provide informed consent 2. Require urgent surgery within 24 hours of first consultation to the Gynecological Oncology team 3. Are undergoing neoadjuvant radiation therapy 4. Have a previously documented history of dementia 5. Have cognitive, language, vision, or hearing impairment that impacts ability to understand the directions for the completion of the study instruments 6. Are participating in a clinical trial investigating a new systemic therapy
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What it tests

  • Clinical Frailty Scale
  • Frailty Phenotype
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Where

4 sites
Juravinksi Hospital
Hamilton, Canada
Credit Valley Hospital
Mississauga, Canada
Sunnybrook
Toronto, Canada
University Health Network
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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