Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
FARGO
1 other identifier
observational
280
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedStudy Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedApril 16, 2025
April 1, 2025
1.9 years
January 31, 2023
April 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
All-cause death or new disability at 6 months
Disability status is determined using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). New disability at any time point is based according to the following criteria that account for baseline disability scores: 1. For individuals with a disability score of \<25% at baseline, new disability is defined as a disability score ≥25% at follow-up; 2. For individuals with a disability score ≥25%, new disability is defined an increase in disability score of ≥8%. Vascular death is defined as any death with a vascular cause and includes those deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery), pulmonary embolus, hemorrhage, or deaths due to an unknown cause. Non-vascular death is defined as any death due to a clearly documented non-vascular cause (e.g. trauma, infection, malignancy).
6 months
Secondary Outcomes (17)
All cause death
28 days and 1 year
Oncologic Outcomes: Progression Free Survival (PFS)
at 6 and 12 months
Oncologic Outcomes: Cancer-specific death
at 6 and 12 months
New Disability
28 days, 6 months and 1 year after surgery
Major vascular complications
at 28 days, 6 months, and 1 year after surgery
- +12 more secondary outcomes
Study Arms (4)
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
A way to summarize the overall level of fitness or frailty of an older adult after they had been evaluated by an experienced clinician
Defined by the presence of three from the following five clinical features: weakness, slow walking speed, unintentional weight loss, exhaustion, and low physical activity
Eligibility Criteria
FARGO will recruit patients aged 55 or older, with confirmed or suspected gynecologic cancer, undergoing cytoreductive or high-risk surgery with or without chemotherapy.
You may qualify if:
- Age must be 55 years or older at registration
- Must meet any one of the following criteria:
- Have stage II-IV ovarian or endometrial cancer, undergoing cytoreductive surgery via laparotomy, with or without neoadjuvant chemotherapy (NACT)
- Have any stage endometrial, uterine or cervical cancer planned for laparotomy where laparoscopy is deemed unfeasible/high-risk due to comorbidities
- Are undergoing laparotomy for pelvic mass, highly suspicious for malignancy; or
- Are undergoing laparotomy for gynecologic malignancy recurrence.
You may not qualify if:
- Unable to provide informed consent
- Require urgent surgery within 24 hours of first consultation to the Gynecological Oncology team
- Are undergoing neoadjuvant radiation therapy
- Have a previously documented history of dementia
- Have cognitive, language, vision, or hearing impairment that impacts ability to understand the directions for the completion of the study instruments
- Are participating in a clinical trial investigating a new systemic therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Juravinksi Hospital
Hamilton, Ontario, L8V 1C3, Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Sunnybrook
Toronto, Ontario, M4N 3M5, Canada
University Health Network
Toronto, Ontario, M5G 2Z5, Canada
Related Publications (1)
Nguyen JMV, Vicus D, Hogen L, Zigras T, Pare G, Chong M, Benitez YR, Devereaux PJ, Ofori S, Borges FK, Di Sante E, Miletic D, Panus O, Vincent J, Ramasundarahettige C, Nene S, Patel A, Marcucci M. Frailty Assessment for Risk prediction in Gynecologic Oncology patients undergoing surgery and chemotherapy (FARGO) study protocol: Rationale and design of a multi-centre prospective cohort study. PLoS One. 2025 Jul 28;20(7):e0325651. doi: 10.1371/journal.pone.0325651. eCollection 2025.
PMID: 40720507DERIVED
Biospecimen
Only participants providing specific separate consent will be enrolled in the biobank study. We will collect blood samples from patients at baseline, i.e., before and after starting the NACT and/or before surgery, and then at 28 days after surgery, 6 months and 12 months. We will collect EDTA tubes to obtain both plasma and whole blood for DNA analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maura Marcucci, MD
Population Health Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 22, 2023
Study Start
June 15, 2023
Primary Completion
May 1, 2025
Study Completion
October 1, 2025
Last Updated
April 16, 2025
Record last verified: 2025-04