90-Day Mortality After Emergency Department Discharge in Advanced Cancer (CARE-90)

September 3, 2025 updated by: Galip Can Uyar, Ankara Etlik City Hospital

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

1250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06210
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Observational Chart Review

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

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.
30 days after ED discharge
30-Day Emergency Department Re-admission
Time Frame: 30 days after ED discharge
Proportion of patients discharged from the emergency department who return within 30 days for any cause. Re-admissions will be verified through hospital records.
30 days after ED discharge
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.
90 days after ED discharge
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)
90 days after ED visit
Correlation between Body Mass Index (BMI) and 90-Day Mortality
Time Frame: 90 days after ED visit
BMI (kg/m²), calculated from body weight (kg) and height (m²) recorded in hospital records.
90 days after ED visit
Correlation between CRP/Albumin Ratio and 90-Day Mortality
Time Frame: 90 days after ED visit
CRP/Albumin ratio (mg/L ÷ g/dL), derived from laboratory test results in hospital records
90 days after ED visit
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
Correlation between Hemoglobin and 90-Day Mortality
Time Frame: 90 days after ED visit
Hemoglobin concentration (g/dL), measured by standard hospital laboratory tests
90 days after ED visit
Correlation between Lactate Dehydrogenase (LDH) and 90-Day Mortality
Time Frame: 90 days after ED visit
Lactate Dehydrogenase (U/L), measured by standard hospital laboratory tests
90 days after ED visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

August 24, 2025

First Submitted That Met QC Criteria

September 3, 2025

First Posted (Estimated)

September 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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