Advanced CancerCARE-90NCT07167095
90-Day Mortality After Emergency Department Discharge in Advanced Cancer
An observational study of Advanced Cancer and Mortality, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study investigates factors associated with 90-day mortality among patients with advanced cancer who present to the emergency department (ED). The study will include stage IV solid tumor patients who visited the ED of Etlik City Hospital between December 2022 and March 2025. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Mortality, Oncology
- What is being tested?
- Retrospective Data Collection and Analysis
- Type of treatment
- Injection or infusion
- How many people
- 1,250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (aged 18 years and older) with stage IV solid tumors who presented to the emergency department of Etlik City Hospital (Ankara, Türkiye) between December 2022 and March 2025. Eligible patients must have received systemic anticancer therapy within the preceding 6 months. Both patients discharged from the ED and those who were hospitalized or who died during their ED visit are included. The estimated enrollment is 1,250 patients.
Who may be able to join
- Age ≥18 years
- Pathologically confirmed stage IV (metastatic) solid malignancy
- Followed at Etlik City Hospital, Department of Medical Oncology
- Presented to the emergency department between December 2022 and March 2025
- Either discharged on the same day, admitted to the hospital, or died during the ED visit
- Received systemic anticancer therapy (chemotherapy, immunotherapy, targeted therapy, or hormonal therapy) within the past 6 months
- Availability of complete clinical and laboratory data
Who cannot join
- Stage I-III cancer patients
- Patients not receiving systemic therapy, only palliative/supportive care
- Patients followed in other oncology centers but presenting to Etlik City Hospital ED
- Patients with hematologic malignancies (e.g., leukemia, lymphoma, multiple myeloma)
- Patients with missing clinical or laboratory data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06210
About this study
Official title: Evaluation of Factors Affecting 90-Day Mortality After Emergency Department Discharge in Patients With Advanced Cancer
This retrospective observational study investigates factors associated with 90-day mortality among patients with advanced cancer who present to the emergency department (ED). The study will include stage IV solid tumor patients who visited the ED of Etlik City Hospital between December 2022 and March 2025. Demographic, clinical, and laboratory parameters such as performance status, nutritional and inflammatory markers, and biochemical values will be analyzed. The primary objective is to identify prognostic indicators that predict short-term mortality following ED visits. By establishing risk profiles, the study aims to optimize patient triage, guide timely referral to supportive and palliative care services, and improve overall care strategies for advanced cancer patients in acute settings.
Read the detailed description
Patients with advanced-stage cancer frequently present to emergency departments (EDs) due to complications related to disease progression, treatment side effects, or acute clinical deterioration. Such unplanned visits represent a critical point in the trajectory of cancer care, as they are often associated with poor short-term outcomes, repeated hospitalizations, and increased healthcare burden. Identifying reliable predictors of mortality following ED discharge is therefore essential for improving triage processes, tailoring management strategies, and ensuring timely referral to supportive or palliative care.
This retrospective cohort study will evaluate prognostic factors associated with 90-day mortality among patients with stage IV solid tumors presenting to the ED of Etlik City Hospital between December 2022 and March 2025. The study population will consist of patients who were discharged on the same day, admitted to the hospital, or who died during their ED visit. Clinical data will be retrieved from the hospital information system, and mortality outcomes will be verified using both institutional records and the national death registry.
Collected parameters will include demographic variables (age, sex, body mass index, smoking history), disease characteristics (primary tumor type, metastatic sites, prior systemic treatment), performance status (ECOG score), and laboratory values routinely obtained during ED visits (hemoglobin, leukocyte and platelet counts, neutrophil-to-lymphocyte ratio, C-reactive protein, albumin, lactate dehydrogenase, renal and liver function tests, and electrolytes). The primary endpoint will be 90-day all-cause mortality after ED presentation. Secondary outcomes will include in-hospital mortality during ED stay, 30-day ED re-admission rates, and 90-day re-hospitalizations.
Statistical analyses will be conducted to assess associations between clinical and laboratory variables and short-term mortality. Group comparisons will be performed using chi-square tests, Fisher's exact test, independent t-test, or Mann-Whitney U test, as appropriate. Multivariable logistic regression models will identify independent predictors of 90-day mortality, while Kaplan-Meier and Cox regression analyses will explore survival differences across patient subgroups stratified by ECOG status, albumin, BMI, and inflammatory markers. Post-hoc power analysis will be conducted to ensure robustness of the findings.
Existing literature highlights the prognostic significance of poor performance status, malnutrition, and systemic inflammation in cancer patients presenting to EDs. Low serum albumin (<3.5 g/dL), high neutrophil-to-lymphocyte ratio, low hemoglobin, and elevated LDH have consistently been associated with higher mortality risk. Similarly, unplanned ED visits often correlate with advanced disease burden, impaired quality of life, and reduced survival. However, most available studies are limited by small sample sizes, heterogeneous populations, or lack of integration between clinical and laboratory data. By analyzing a large cohort of 1,250-1,650 patients from a single tertiary cancer center, this study aims to overcome these limitations and provide a more comprehensive understanding of risk profiles in this vulnerable population.
The findings are expected to contribute valuable insights into the early identification of high-risk patients at the time of ED admission. Ultimately, these results could support the development of evidence-based prognostic models that inform clinical decision-making, improve allocation of healthcare resources, and enhance the integration of supportive and palliative care interventions for patients with advanced malignancies.
- Conditions
- Advanced Cancer, Mortality, Oncology, Emergency Department Admission, Metastatic Solid Tumors
- Being tested
- Retrospective Data Collection and Analysis
- Keywords
- 90-Day Mortality, Emergency Department, Prognostic Factors, Performance Status, Nutritional and Inflammatory Markers, Oncology Supportive Care, Palliative Care
- Medical subject headings
- Neoplasms, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Data Collection and AnalysisOther
Also called Observational Chart Review
This intervention refers to retrospective evaluation of clinical and laboratory data of advanced cancer patients who presented to the emergency department between December 2022 and March 2025. Data will be extracted from the hospital information system (HBYS) and national death registry (e-Nabız). Parameters include demographics, ECOG performance status, primary tumor type, metastatic sites, laboratory markers (e.g., NLR, CRP, albumin, LDH), and outcomes such as 90-day mortality, re-admissions, and re-hospitalizations. No experimental treatment, drug, or device is administered as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Cancer Patients Presenting to the Emergency Department | This retrospective cohort includes adult patients (≥18 years) with pathologically confirmed stage IV solid tumors who presented to the emergency department of Etlik City Hospital between December 2022 and March 2025. Patients were eligible if they had received systemic anticancer therapy within the previous 6 months and had complete clinical and laboratory records. Both patients discharged from the ED and those who were admitted or died during the ED visit are included. Data collected include demographic characteristics, performance status, primary tumor type, metastatic sites, reasons for ED admission, laboratory values, and subsequent outcomes. The cohort will be analyzed to identify prognostic factors associated with 90-day mortality, ED re-admissions, and re-hospitalizations. Receives: Other: Retrospective Data Collection and Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-Day All-Cause Mortality After Emergency Department Visit
All-cause mortality within 90 days following presentation to the emergency department among patients with stage IV solid tumors. Mortality status will be confirmed using the hospital information system (HBYS) and the national death registry (e-Nabız). Both in-hospital and out-of-hospital deaths will be included.
Measured: 90 days after emergency department visit
Secondary outcomes (9)
In-Hospital Mortality During Emergency Department Visit
Proportion of patients with stage IV solid tumors who die during the index emergency department visit. Mortality will be confirmed via hospital records.
Measured: 30 days after ED discharge
30-Day Emergency Department Re-admission
Proportion of patients discharged from the emergency department who return within 30 days for any cause. Re-admissions will be verified through hospital records.
Measured: 30 days after ED discharge
90-Day Hospital Re-admission Rate
Proportion of patients discharged from the ED who are subsequently hospitalized within 90 days. Re-hospitalizations will be tracked using the hospital information system.
Measured: 90 days after ED discharge
Correlation between ECOG Performance Status and 90-Day Mortality
Eastern Cooperative Oncology Group (ECOG) Performance Status scale, which ranges from 0 (fully active) to 4 (completely disabled)
Measured: 90 days after ED visit
Correlation between Body Mass Index (BMI) and 90-Day Mortality
BMI (kg/m²), calculated from body weight (kg) and height (m²) recorded in hospital records.
Measured: 90 days after ED visit
Correlation between CRP/Albumin Ratio and 90-Day Mortality
CRP/Albumin ratio (mg/L ÷ g/dL), derived from laboratory test results in hospital records
Measured: 90 days after ED visit
Correlation between Neutrophil-to-Lymphocyte Ratio (NLR) and 90-Day Mortality
Neutrophil-to-Lymphocyte Ratio, calculated from absolute neutrophil and lymphocyte counts in hospital laboratory records
Measured: 90 days after ED visit
Correlation between Hemoglobin and 90-Day Mortality
Hemoglobin concentration (g/dL), measured by standard hospital laboratory tests
Measured: 90 days after ED visit
Correlation between Lactate Dehydrogenase (LDH) and 90-Day Mortality
Lactate Dehydrogenase (U/L), measured by standard hospital laboratory tests
Measured: 90 days after ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Dec 2022
- Primary completion1 Jan 2023
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Retrospective
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167095
- Sponsor's protocol ID
- AEŞH-BADEK2-2025-242
- Other IDs
- AEŞH-BADEK2-2025-242
- Acronym
- CARE-90
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Affecting 90-Day Mortality After Emergency Department Discharge in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT07167095
- Acronym / sponsor ID
- CARE-90 / AEŞH-BADEK2-2025-242
- Conditions
- Advanced Cancer, Mortality, Oncology, Emergency Department Admission, Metastatic Solid Tumors
- Keywords
- 90-Day Mortality, Emergency Department, Prognostic Factors, Performance Status, Nutritional and Inflammatory Markers, Oncology Supportive Care, Palliative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 11 Sep 2025 (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.
This retrospective observational study investigates factors associated with 90-day mortality among patients with advanced cancer who present to the emergency department (ED). The study will include stage IV solid tumor patients who visited the ED of Etlik City Hospital between December 2022 and March 2025. Demographic, clinical, and laboratory parameters such as performance status, nutritional and inflammatory markers, and biochemical values will be analyzed. The primary objective is to identify prognostic indicators that predict short-term mortality following ED visits. By establishing risk profiles, the study aims to optimize patient triage, guide timely referral to supportive and palliative care services, and improve overall care strategies for advanced cancer patients in acute settings.
Detailed description
Patients with advanced-stage cancer frequently present to emergency departments (EDs) due to complications related to disease progression, treatment side effects, or acute clinical deterioration. Such unplanned visits represent a critical point in the trajectory of cancer care, as they are often associated with poor short-term outcomes, repeated hospitalizations, and increased healthcare burden. Identifying reliable predictors of mortality following ED discharge is therefore essential for improving triage processes, tailoring management strategies, and ensuring timely referral to supportive or palliative care.
This retrospective cohort study will evaluate prognostic factors associated with 90-day mortality among patients with stage IV solid tumors presenting to the ED of Etlik City Hospital between December 2022 and March 2025. The study population will consist of patients who were discharged on the same day, admitted to the hospital, or who died during their ED visit. Clinical data will be retrieved from the hospital information system, and mortality outcomes will be verified using both institutional records and the national death registry.
Collected parameters will include demographic variables (age, sex, body mass index, smoking history), disease characteristics (primary tumor type, metastatic sites, prior systemic treatment), performance status (ECOG score), and laboratory values routinely obtained during ED visits (hemoglobin, leukocyte and platelet counts, neutrophil-to-lymphocyte ratio, C-reactive protein, albumin, lactate dehydrogenase, renal and liver function tests, and electrolytes). The primary endpoint will be 90-day all-cause mortality after ED presentation. Secondary outcomes will include in-hospital mortality during ED stay, 30-day ED re-admission rates, and 90-day re-hospitalizations.
Statistical analyses will be conducted to assess associations between clinical and laboratory variables and short-term mortality. Group comparisons will be performed using chi-square tests, Fisher's exact test, independent t-test, or Mann-Whitney U test, as appropriate. Multivariable logistic regression models will identify independent predictors of 90-day mortality, while Kaplan-Meier and Cox regression analyses will explore survival differences across patient subgroups stratified by ECOG status, albumin, BMI, and inflammatory markers. Post-hoc power analysis will be conducted to ensure robustness of the findings.
Existing literature highlights the prognostic significance of poor performance status, malnutrition, and systemic inflammation in cancer patients presenting to EDs. Low serum albumin (<3.5 g/dL), high neutrophil-to-lymphocyte ratio, low hemoglobin, and elevated LDH have consistently been associated with higher mortality risk. Similarly, unplanned ED visits often correlate with advanced disease burden, impaired quality of life, and reduced survival. However, most available studies are limited by small sample sizes, heterogeneous populations, or lack of integration between clinical and laboratory data. By analyzing a large cohort of 1,250-1,650 patients from a single tertiary cancer center, this study aims to overcome these limitations and provide a more comprehensive understanding of risk profiles in this vulnerable population.
The findings are expected to contribute valuable insights into the early identification of high-risk patients at the time of ED admission. Ultimately, these results could support the development of evidence-based prognostic models that inform clinical decision-making, improve allocation of healthcare resources, and enhance the integration of supportive and palliative care interventions for patients with advanced malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Cancer Patients Presenting to the Emergency Department | – | Other: Retrospective Data Collection and AnalysisThis retrospective cohort includes adult patients (≥18 years) with pathologically confirmed stage IV solid tumors who presented to the emergency department of Etlik City Hospital between December 2022 and March 2025. Patients were eligible if they had received systemic anticancer therapy within the previous 6 months and had complete clinical and laboratory records. Both patients discharged from the ED and those who were admitted or died during the ED visit are included. Data collected include demographic characteristics, performance status, primary tumor type, metastatic sites, reasons for ED admission, laboratory values, and subsequent outcomes. The cohort will be analyzed to identify prognostic factors associated with 90-day mortality, ED re-admissions, and re-hospitalizations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18 years and older) with stage IV solid tumors who presented to the emergency department of Etlik City Hospital (Ankara, Türkiye) between December 2022 and March 2025. Eligible patients must have received systemic anticancer therapy within the preceding 6 months. Both patients discharged from the ED and those who were hospitalized or who died during their ED visit are included. The estimated enrollment is 1,250 patients.
Key inclusion criteria (7 listed)
- Age ≥18 years
- Pathologically confirmed stage IV (metastatic) solid malignancy
- Followed at Etlik City Hospital, Department of Medical Oncology
- Presented to the emergency department between December 2022 and March 2025
- Either discharged on the same day, admitted to the hospital, or died during the ED visit
Key exclusion criteria (5 listed)
- Stage I-III cancer patients
- Patients not receiving systemic therapy, only palliative/supportive care
- Patients followed in other oncology centers but presenting to Etlik City Hospital ED
- Patients with hematologic malignancies (e.g., leukemia, lymphoma, multiple myeloma)
- Patients with missing clinical or laboratory data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Data Collection and AnalysisAlso: Observational Chart ReviewThis intervention refers to retrospective evaluation of clinical and laboratory data of advanced cancer patients who presented to the emergency department between December 2022 and March 2025. Data will be extracted from the hospital information system (HBYS) and national death registry (e-Nabız). Parameters include demographics, ECOG performance status, primary tumor type, metastatic sites, laboratory markers (e.g., NLR, CRP, albumin, LDH), and outcomes such as 90-day mortality, re-admissions, and re-hospitalizations. No experimental treatment, drug, or device is administered as part of the study. | Other | Advanced Cancer Patients Presenting to the Emergency Department |
Primary outcome
90-Day All-Cause Mortality After Emergency Department Visit
Time frame: 90 days after emergency department visit
All-cause mortality within 90 days following presentation to the emergency department among patients with stage IV solid tumors. Mortality status will be confirmed using the hospital information system (HBYS) and the national death registry (e-Nabız). Both in-hospital and out-of-hospital deaths will be included.
9 secondary outcomes
In-Hospital Mortality During Emergency Department Visit
Time frame: 30 days after ED discharge
30-Day Emergency Department Re-admission
Time frame: 30 days after ED discharge
90-Day Hospital Re-admission Rate
Time frame: 90 days after ED discharge
Correlation between ECOG Performance Status and 90-Day Mortality
Time frame: 90 days after ED visit
Correlation between Body Mass Index (BMI) and 90-Day Mortality
Time frame: 90 days after ED visit
Correlation between CRP/Albumin Ratio and 90-Day Mortality
Time frame: 90 days after ED visit
Correlation between Neutrophil-to-Lymphocyte Ratio (NLR) and 90-Day Mortality
Time frame: 90 days after ED visit
Correlation between Hemoglobin and 90-Day Mortality
Time frame: 90 days after ED visit
Correlation between Lactate Dehydrogenase (LDH) and 90-Day Mortality
Time frame: 90 days after ED visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Mortality, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-Day All-Cause Mortality After Emergency Department Visit (time frame: 90 days after emergency department visit). 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 11 Sep 2025.