UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061116 |
|---|---|
| Receipt number | R000069926 |
| Scientific Title | Development of a Prognostic Model for Cancer Patients in a Palliative Care Unit |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/31 16:59:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of a Prognostic Model for Cancer Patients in a Palliative Care Unit
Acronym
Development of a Prognostic Model for Cancer Patients in a Palliative Care Unit
Scientific Title
Development of a Prognostic Model for Cancer Patients in a Palliative Care Unit
Scientific Title:Acronym
Development of a Prognostic Model for Cancer Patients in a Palliative Care Unit
Region
| Japan |
Condition
Condition
Advanced cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a prognostic model for predicting 30-day mortality in patients with advanced cancer at initial admission to a palliative care unit.
Basic objectives2
Others
Basic objectives -Others
To assess the distribution and time course of clinical findings within 30 days after admission.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day mortality after initial admission to a palliative care unit (defined as death from any cause within 30 days of the first admission date).
Key secondary outcomes
Distribution and time course of clinical findings during the first 30 days after admission.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to the palliative care unit at Aizu Medical Center, Fukushima Medical University, between May 2013 and November 2025 will be eligible if they meet the following criteria:
1. Patients aged 18 years or older
2. Patients diagnosed with advanced cancer (locally advanced or metastatic disease)
3. Patients admitted for the first time to the palliative care unit at Fukushima Medical University Aizu Medical Center
Key exclusion criteria
1. Patients or their legally authorized representatives who refuse participation in the study
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Suzuki |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Laboratory of Japanese Traditional (Kampo) Medicine
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima 969-3492, Japan
TEL
0242-75-2100
masuzuki@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Kayo |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Laboratory of Japanese Traditional (Kampo) Medicine
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima 969-3492, Japan
TEL
0242-75-2100
Homepage URL
k-takumi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1, Hikarigaoka, Fukushima, Japan
Tel
024-547-1825
rs@fmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prognostic model will be developed to predict 30-day mortality among patients with advanced cancer who are admitted for the first time to a palliative care unit at a single medical institution in Japan, based on clinical findings obtained at admission (within 24 hours before or after admission). The performance of the model will be evaluated in terms of discrimination, calibration, and clinical utility. In addition, the distribution and temporal changes of the clinical findings used in the primary analysis will be descriptively assessed during the first 30 days after admission. The following variables will be collected: sex, age, primary tumor site, sites of metastasis, systolic blood pressure, pulse rate, body temperature, oxygen saturation, altered consciousness, palpable radial artery pulse, abnormal breathing pattern, rattle, mandibular breathing, peripheral cyanosis, lower extremity edema, dyspnea, anorexia, dysphagia for liquids, Palliative Performance Scale, daily opioid dose (morphine equivalent), neutrophil count, lymphocyte count, hemoglobin, platelet count, albumin, aspartate aminotransferase, blood urea nitrogen, creatinine, lactate dehydrogenase, total bilirubin, C-reactive protein, vital status (dead/alive), and date of death.
Management information
Registered date
| 2026 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069926
