An observational study in Ovarian Cancer, Cognitive Decline and Delirium, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Cognitive decline and delirium are common geriatric syndromes that adversely affect treatment adherence, functional independence, quality of life, and survival in older adults with cancer. Women aged 70 years and older with ovarian cancer are particularly vulnerable because of the combined effects of aging, frailty, multimorbidity, and cancer-related factors. However, the prevalence, incidence, determinants, and longitudinal trajectories of cognitive impairment and delirium in this population remain poorly characterized, and validated strategies for risk stratification are lacking.
The C.R.O.W.N. (Identification of clinical, functional and biological predictors of Cognitive decline and deliRium in Older Women affected by ovarian caNcer) study is a prospective, single-center, longitudinal observational cohort study designed to identify clinical, functional, and biological predictors of cognitive decline and delirium in older women with ovarian cancer undergoing active treatment. Women aged 70 years or older with newly diagnosed ovarian cancer or first relapse will undergo a comprehensive geriatric assessment before treatment initiation and will be followed for 12 months. Assessments will include standardized cognitive and neuropsychological testing, frailty and functional evaluation, quality-of-life assessment, and systematic delirium screening during hospitalizations. Blood samples will be collected at baseline to measure biomarkers of neurodegeneration and inflammation. Telemonitoring will complement in-person follow-up visits to improve retention and longitudinal assessment.
The primary objective is to evaluate the prevalence, incidence, and trajectory of cognitive decline and to identify its clinical, functional, and biological predictors. Secondary objectives include evaluating the occurrence and predictors of delirium, assessing the impact of cognitive disorders on disability, hospitalization, mortality, and quality of life, and developing an integrated risk prediction model combining geriatric assessment and blood-based biomarkers. The study aims to improve early identification of patients at high risk for adverse cognitive outcomes and support personalized oncogeriatric care pathways.
Cognitive decline and delirium are frequent and clinically relevant geriatric syndromes among older adults with cancer. These conditions are associated with reduced treatment adherence, functional decline, poorer quality of life, increased hospitalization, and mortality. In older women with ovarian cancer, cognitive outcomes are influenced by a complex interaction between aging-related vulnerability, frailty, multimorbidity, cancer characteristics, and oncological treatments. Despite the increasing use of Comprehensive Geriatric Assessment (CGA) in oncology, important gaps remain in identifying patients at highest risk for cognitive decline and delirium and in understanding the biological mechanisms underlying these conditions.
The C.R.O.W.N. (Identification of clinical, functional and biological predictors of Cognitive decline and deliRium in Older Women affected by ovarian caNcer) study is a prospective, longitudinal, single-center observational cohort study designed to identify clinical, functional, and biological predictors of cognitive decline and delirium in older women with ovarian cancer undergoing active treatment.
Women aged 70 years or older with newly diagnosed ovarian cancer, regardless of disease stage, or with first disease recurrence will be enrolled before the initiation of any oncological treatment or invasive procedure. All participants will undergo a standardized Comprehensive Geriatric Assessment, including evaluation of comorbidities, medications, frailty, nutritional status, physical performance, disability, mood, quality of life, and cognitive function.
Cognitive assessment will combine subjective and objective measures. Standardized neuropsychological tests will evaluate memory, executive function, attention, verbal fluency, and global cognition, while validated patient-reported outcome measures will assess perceived cognitive impairment. Participants will undergo evaluations at baseline, 6 months, and 12 months to characterize longitudinal cognitive trajectories.
During hospital admissions, including postoperative hospitalization, participants will be systematically screened for delirium using validated assessment tools. In addition, a structured telemonitoring program based on telephone contacts, video consultations when necessary, and remote cognitive screening will support follow-up, minimize missing data, and facilitate early identification of cognitive changes.
Blood samples collected before treatment initiation will be analyzed to measure biomarkers of neurodegeneration and systemic inflammation, including neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), phosphorylated tau, amyloid-beta peptides, inflammatory cytokines, C-reactive protein, and other laboratory markers. These biomarkers will be integrated with clinical and geriatric assessment data to investigate their contribution to cognitive decline and delirium.
The primary objective is to determine the prevalence and incidence of cognitive decline and to identify clinical, functional, and biological predictors associated with longitudinal cognitive deterioration. Secondary objectives include evaluating the incidence and predictors of delirium, assessing the association of cognitive disorders with disability, hospitalization, mortality, and quality of life, and developing a multivariable risk prediction model capable of stratifying patients according to their probability of adverse cognitive outcomes.
By integrating comprehensive geriatric assessment with blood-based biomarkers and longitudinal follow-up, the C.R.O.W.N. study aims to improve the early identification of vulnerable older women with ovarian cancer, support individualized oncogeriatric care, and provide evidence to inform future preventive and therapeutic strategies targeting cancer-related cognitive impairment and delirium.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 205 is close to the median of 200 across 616 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Women aged ≥70 years with ovarian cancer undergoing active treatment will be recruited from the Oncogeriatric Outpatient Clinic of the Palliative Care and Geriatric Oncology Unit. Eligible patients will be referred by the Gynecologic Oncology Unit for pre-treatment geriatric assessment during the pre-admission evaluation, upon request from the Women's Cancer Day Hospital or the Clinical Pharmacology Day Hospital, or following multidisciplinary discussion at the Ovarian Cancer Tumor Board.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women aged 70 years or older with newly diagnosed ovarian cancer (any stage) or first disease recurrence, enrolled before initiation of any cancer treatment or invasive procedure. Participants will undergo comprehensive geriatric assessment, cognitive and functional evaluations, delirium screening during hospitalization, blood biomarker assessment, and longitudinal follow-up for 12 months.
Incident Cognitive Decline
Incident cognitive decline will be defined as a clinically meaningful decline in cognitive performance, measured by a decrease of 1-3 points in the Mini-Mental State Examination (MMSE), or a decrease of ≥1.5 standard deviations in the composite score of the Trail Making Test (TMT), Hopkins Verbal Learning Test-Revised (HVLT-R), and Controlled Oral Word Association Test (COWA), and/or a decrease of ≥0.5 standard deviations in the Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairment (FACT-Cog PCI) score.
Time frame: Baseline to 12 months
Prevalent Cognitive Impairment
Prevalent cognitive impairment at baseline, defined as an MMSE score \<26 and/or objective cognitive impairment based on the composite score of the Trail Making Test (TMT), Hopkins Verbal Learning Test-Revised (HVLT-R), and Controlled Oral Word Association Test (COWA), and/or subjective cognitive impairment defined by a FACT-Cog Perceived Cognitive Impairment (PCI) score \<54.
Time frame: Baseline
Incident Delirium
Occurrence of delirium during hospitalization, including postoperative delirium, defined as a positive 4AT screening confirmed by the Confusion Assessment Method (CAM).
Time frame: During hospitalization, up to 12 months
Incident Disability
Incident disability, defined as the development of new dependence in one or more Activities of Daily Living (ADL) or Instrumental Activities of Daily Living (IADL) during follow-up.
Time frame: Baseline to 12 months
Change in Quality of Life
Decline in quality of life, defined as a decrease of at least 10 points in the EORTC QLQ-C30 global health status score during follow-up.
Time frame: Baseline to 12 months
All-Cause Mortality
All-cause mortality occurring during the follow-up period.
Time frame: Baseline to 12 months
Hospitalizations
Occurrence of all-cause hospitalizations during the follow-up period.
Time frame: Baseline to 12 months
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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