Ovarian CancerCROWNNCT07716800
Predictors of Cognitive Decline and Delirium in Older Women With Ovarian Cancer
An observational study of Ovarian Cancer and Cognitive Decline, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Cognitive Decline, Delirium
- How many people
- 205 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- Female sex with ovarian cancer.
- Age ≥70 years.
- Newly diagnosed ovarian cancer (any stage) or first disease recurrence.
- Evaluation before initiation of any anticancer treatment or invasive procedure (e.g., primary cytoreductive surgery, neoadjuvant chemotherapy, image-guided biopsy, or exploratory laparoscopy).
- Ability to understand and provide written informed consent, or availability of a legally authorized representative to provide consent.
Who cannot join
- Age <70 years.
- Refusal or inability to provide written informed consent and absence of a legally authorized representative.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Identification of Clinical, Functional and Biological Predictors of Cognitive Decline and deliRium in Older Women Affected by Ovarian caNcer: the C.R.O.W.N. Study
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.
Read the detailed description
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.
- Conditions
- Ovarian Cancer, Cognitive Decline, Delirium
- Medical subject headings
- Ovarian Neoplasms, Cognitive Dysfunction, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older Women With Ovarian Cancer | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (6)
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.
Measured: Baseline
Incident Delirium
Occurrence of delirium during hospitalization, including postoperative delirium, defined as a positive 4AT screening confirmed by the Confusion Assessment Method (CAM).
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
All-Cause Mortality
All-cause mortality occurring during the follow-up period.
Measured: Baseline to 12 months
Hospitalizations
Occurrence of all-cause hospitalizations during the follow-up period.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zazzara Maria Beatrice, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Maria Beatrice Zazzara, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716800
- Sponsor's protocol ID
- 27584
- Acronym
- CROWN
- Status last verified
- Jun 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Clinical, Functional and Biological Predictors of Cognitive Decline and deliRium in Older Women Affected by Ovarian caNcer: the C.R.O.W.N. Study
- ClinicalTrials.gov ID
- NCT07716800
- Acronym / sponsor ID
- CROWN / 27584
- Conditions
- Ovarian Cancer, Cognitive Decline, Delirium
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Women With Ovarian Cancer | – | –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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Female sex with ovarian cancer.
- Age ≥70 years.
- Newly diagnosed ovarian cancer (any stage) or first disease recurrence.
- Evaluation before initiation of any anticancer treatment or invasive procedure (e.g., primary cytoreductive surgery, neoadjuvant chemotherapy, image-guided biopsy, or exploratory laparoscopy).
- Ability to understand and provide written informed consent, or availability of a legally authorized representative to provide consent.
Key exclusion criteria (2 listed)
- Age <70 years.
- Refusal or inability to provide written informed consent and absence of a legally authorized representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident Cognitive Decline
Time frame: Baseline to 12 months
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.
6 secondary outcomes
Prevalent Cognitive Impairment
Time frame: Baseline
Incident Delirium
Time frame: During hospitalization, up to 12 months
Incident Disability
Time frame: Baseline to 12 months
Change in Quality of Life
Time frame: Baseline to 12 months
All-Cause Mortality
Time frame: Baseline to 12 months
Hospitalizations
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Beatrice Zazzara principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Cognitive Decline, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Beatrice Zazzara, MD (+390630151, mariabeatrice.zazzara@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident Cognitive Decline (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.