NCT05810701 FRAGINOC Study: Screening and Geriatric Assessment and Intervention in Older Patients With Epithelial Ovarian Cancer
| NCT ID | NCT05810701 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-02-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ovarian cancer (OC) is the fifth most common cause of cancer death. More than 40% are older than 70 years. The standard treatment is radical surgery combined with chemotherapy. More than 40% of the Danish patients will never undergo surgery. Frail and immunodeficient older patients are at higher risk of complications, and immunomodulating treatment as chemotherapy results in different outcomes in comparable patients. No accurate validated screening tool to identify frail and immunodeficient OC women exists. Optimization through comprehensive geriatric assessment (CGA) and physical training before and during treatment may improve outcomes and decrease associated risks. Aim: Primary endpoints will be to determine whether a CGA and physical training vs standard of care can increase the proportion of patients later on referred to interval debulking surgery, and examine the performance of validated screening tests in predicting impairments in CGA. Other endpoints will be to evaluate if intervention can improve completion of chemotherapy, to examine the association between frailty screening scores and selected biomarkers with treatment outcomes, including complications and quality of life, and ultimately to develop an improved frailty screening tool based on known screening tools, functional tests and biomarkers identifying patients who will benefit from CGA. Method: This is a nationwide, randomized intervention study. Patients ≥70 years diagnosed with primary OC at the Gynecological departments of Rigshospitalet, Odense and Roskilde University Hospitals will be included. In an interdisciplinary collaboration between medical specialists in oncology, gynecology and geriatrics, included patients will be screened for frailty using validated screening tools and functional tests. Specific biomarkers and immunologic profile will be assessed in all patients. Patients selected for neoadjuvant chemotherapy will be randomized to receive CGA or standard of care. Patients selected for primary debulking surgery or palliation will be followed in an observational cohort. Perspective: The development of a validated screening tool for frailty assessment and immunological status will help us identify frail patients who may need optimization before treatment, resulting in more patients getting optimal treatment (either surgery or chemotherapy), prevent post-treatment complications and avoid palliative patients from undergoing a redundant complex treatment.
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed ovarian cancer * Capable of understanding written and oral danish Exclusion Criteria: * Other active cancers in the preceding 5 years * Severe psychiatric disease Patients referred to primary debulking surgery will be followed in a observational design
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05810701 clinical trial?
This trial is open to female participants only, aged 70 Years or older, up to 120 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05810701 currently recruiting?
Yes, NCT05810701 is actively recruiting participants. Contact the research team at tine.henrichsen.schnack@rsyd.dk for enrollment information.
Where is the NCT05810701 trial being conducted?
This trial is being conducted at Odense, Denmark, Vejle, Denmark, Roskilde, Denmark, Copenhagen, Denmark and 1 additional location.
Who is sponsoring the NCT05810701 clinical trial?
NCT05810701 is sponsored by Odense University Hospital. The trial plans to enroll 300 participants.
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