|

Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients

RECRUITINGSponsored by Population Health Research Institute
Actively Recruiting
SponsorPopulation Health Research Institute
Started2023-06-15
Est. completion2025-05
Eligibility
Age55 Years – 110 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 55 Years – 110 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions4

CancerFrailtyGynecologic CancerOncology

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.