Clinical trial · Observational
Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients
Frailty Assessments for Risk Assessment in Gynecologic Oncology Patients Undergoing Surgery and Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Frailty | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Frailty Scale | Diagnostic Test | — | UNRESOLVED |
| Frailty Phenotype | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Group A
- description
- 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.
- interventionNames
- Diagnostic Test: Clinical Frailty Scale
- Diagnostic Test: Frailty Phenotype
- label
- Group B
- description
- 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.
- interventionNames
- Diagnostic Test: Clinical Frailty Scale
- Diagnostic Test: Frailty Phenotype
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNguyen 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 40720507