- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07167095
- Original Trial
90-Day Mortality After Emergency Department Discharge in Advanced Cancer (CARE-90)
Evaluation of Factors Affecting 90-Day Mortality After Emergency Department Discharge in Patients With Advanced Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Yenimahalle
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Ankara, Yenimahalle, Turkey (Türkiye), 06210
- Ankara Etlik City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
90 days after emergency department visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In-Hospital Mortality During Emergency Department Visit
Time Frame: 30 days after ED discharge
|
Proportion of patients with stage IV solid tumors who die during the index emergency department visit.
Mortality will be confirmed via hospital records.
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30 days after ED discharge
|
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30-Day Emergency Department Re-admission
Time Frame: 30 days after ED discharge
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Proportion of patients discharged from the emergency department who return within 30 days for any cause.
Re-admissions will be verified through hospital records.
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30 days after ED discharge
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90-Day Hospital Re-admission Rate
Time Frame: 90 days after ED discharge
|
Proportion of patients discharged from the ED who are subsequently hospitalized within 90 days.
Re-hospitalizations will be tracked using the hospital information system.
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90 days after ED discharge
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Correlation between ECOG Performance Status and 90-Day Mortality
Time Frame: 90 days after ED visit
|
Eastern Cooperative Oncology Group (ECOG) Performance Status scale, which ranges from 0 (fully active) to 4 (completely disabled)
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90 days after ED visit
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Correlation between Body Mass Index (BMI) and 90-Day Mortality
Time Frame: 90 days after ED visit
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BMI (kg/m²), calculated from body weight (kg) and height (m²) recorded in hospital records.
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90 days after ED visit
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Correlation between CRP/Albumin Ratio and 90-Day Mortality
Time Frame: 90 days after ED visit
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CRP/Albumin ratio (mg/L ÷ g/dL), derived from laboratory test results in hospital records
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90 days after ED visit
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Correlation between Neutrophil-to-Lymphocyte Ratio (NLR) and 90-Day Mortality
Time Frame: 90 days after ED visit
|
Neutrophil-to-Lymphocyte Ratio, calculated from absolute neutrophil and lymphocyte counts in hospital laboratory records
|
90 days after ED visit
|
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Correlation between Hemoglobin and 90-Day Mortality
Time Frame: 90 days after ED visit
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Hemoglobin concentration (g/dL), measured by standard hospital laboratory tests
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90 days after ED visit
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Correlation between Lactate Dehydrogenase (LDH) and 90-Day Mortality
Time Frame: 90 days after ED visit
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Lactate Dehydrogenase (U/L), measured by standard hospital laboratory tests
|
90 days after ED visit
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-BADEK2-2025-242 (Other Identifier: Etlik City Hospital Scientific Research and Evaluation Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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