Actively Recruiting

Age: 55Years - 110Years
FEMALE
NCT05738252

Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

Led by Population Health Research Institute · Updated on 2025-04-16

280

Participants Needed

4

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

Who Can Participate

Age: 55Years - 110Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 55 years or older at registration
  • Have stage II-IV ovarian or endometrial cancer and undergoing cytoreductive surgery via laparotomy, with or without neoadjuvant chemotherapy
  • Have any stage endometrial, uterine, or cervical cancer planned for laparotomy when laparoscopy is not feasible or high-risk due to other health conditions
  • Undergoing laparotomy for a pelvic mass highly suspicious for malignancy
  • Undergoing laparotomy for recurrence of gynecologic malignancy
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Require urgent surgery within 24 hours of first consultation to the Gynecological Oncology team
  • Undergoing neoadjuvant radiation therapy
  • Have a previously documented history of dementia
  • Have cognitive, language, vision, or hearing impairments affecting ability to complete study tasks
  • Currently participating in a clinical trial investigating a new systemic therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Juravinksi Hospital

Hamilton, Ontario, Canada, L8V 1C3

Actively Recruiting

2

Credit Valley Hospital

Mississauga, Ontario, Canada, L5M 2N1

Actively Recruiting

3

Sunnybrook

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

4

University Health Network

Toronto, Ontario, Canada, M5G 2Z5

Actively Recruiting

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Research Team

J

Julie My Van Nguyen, MD

CONTACT

E

Emily Di Sante, MA

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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