NCT05738252 Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
| NCT ID | NCT05738252 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Population Health Research Institute |
| Condition | Gynecologic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-06-15 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 280 participants in total. It began in 2023-06-15 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Maura Marcucci, MD
PRINCIPAL INVESTIGATOR
Population Health Research Institute
Frequently Asked Questions
Who can join the NCT05738252 clinical trial?
This trial is open to female participants only, aged 55 Years or older, up to 110 Years, studying Gynecologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05738252 currently recruiting?
Yes, NCT05738252 is actively recruiting participants. Contact the research team at nguyenjmv@HHSC.CA for enrollment information.
Where is the NCT05738252 trial being conducted?
This trial is being conducted at Hamilton, Canada, Mississauga, Canada, Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT05738252 clinical trial?
NCT05738252 is sponsored by Population Health Research Institute. The principal investigator is Maura Marcucci, MD at Population Health Research Institute. The trial plans to enroll 280 participants.
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