Recruiting

Observational Study

Sponsor:

Population Health Research Institute

Code:

NCT05738252

Conditions

Gynecologic Cancer

Frailty

Oncology

Eligibility Criteria

Sex: Female

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Clinical Frailty Scale

Frailty Phenotype

Study Details

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.

Conditions

Gynecologic Cancer

Frailty

Oncology

Study ID

NCT05738252

Start date

Jun 15, 2023

Status verified date

Apr, 2025

Completion date

Oct, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 55 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

280 participants

Anticipated

Interventions and Outcome Measures

Arms

Group A

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.

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.

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

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.

Interventions

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

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

Primary outcome measure

  • All-cause death or new disability at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Julie My Van Nguyen, MD

905-521-2100nguyenjmv@HHSC.CA

Emily Di Sante, MA

905-521-2100emily.disante@phri.ca

Locations

Juravinksi Hospital

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Contacts

Julie My Van Nguyen, MD

905-521-2100nguyenjmv@HHSC.CA

Credit Valley Hospital

Recruiting

Mississauga, Ontario, Canada, L5M 2N1

Sunnybrook

Recruiting

Toronto, Ontario, Canada, M4N 3M5

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2Z5

Contacts

Liat Hogen, MD

416-946-4501Liat.Hogen@uhn.ca

More Information

Sponsor

Population Health Research Institute

Last update posted

Apr 16, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2025-04-16.