UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038894 |
|---|---|
| Receipt number | R000044348 |
| Scientific Title | Development of biomarker to predict postpoerative delirium and postoperative cognitive decline in cancer patients |
| Date of disclosure of the study information | 2019/12/16 |
| Last modified on | 2021/06/17 22:04:57 |
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Basic information
Public title
Development of biomarker to predict postpoerative delirium and postoperative cognitive decline in cancer patients
Acronym
Delirium Mechanism (DM) study
Scientific Title
Development of biomarker to predict postpoerative delirium and postoperative cognitive decline in cancer patients
Scientific Title:Acronym
Delirium Mechanism (DM) study
Region
| Japan |
Condition
Condition
Postoperative delirium
Postoperative cognitive decline
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a predictive biomarker to predict postoperative delirium and postoperative cognitive decline in cancer patients.
Basic objectives2
Others
Basic objectives -Others
This prospective observational study aims to 1) build a cohort of cancer patients undergoing invasive cancer resection, 2) explore the mechanism of postoperative delirium and postoperative cognitive decline, and 3) develop a biomarker to predict postoperative delirium and postoperative cognitive decline in cancer patients based on the pathology.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Immunological factor associated with the onset of postoperative delirium and postoperative cognitive decline.
Key secondary outcomes
Metabolomics, epigenome, gene expression, clinical factor, physical remark, electroencephalography associated with the onset of postoperative delirium and postoperative cognitive decline.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who plan to undertake highly invasive cancer resection, surgery under general anesthesia generally considered to take over 6 hours or surgery considered as highly invasive based on expert opinion from a surgeon among those come to an outpatient clinic or are admitted to the national cancer center hospital (regardless of the actual surgical time as long as surgical procedure is not substantially changed).
Key exclusion criteria
1. Delirium diagnosis at informed consent
2. Judgement of inappropriateness by the manager or member of research project
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Teruhiko |
| Middle name | |
| Last name | Yoshida |
Organization
National Cancer Center Japan
Division name
Department of Clinical Genomics
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
tyoshida@ncc.go.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Sadahiro |
Organization
National Cancer Center Japan
Division name
National Cancer Center Hospital, Department of Psycho-oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
rsadahir@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Japan
Institute
Department
Personal name
Funding Source
Organization
the Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio University School of Medicine
University of Exeter Medical School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional review board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.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
| 2019 | Year | 12 | Month | 16 | 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
327
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation
A Characteristics, Clinical information
B Biological signature and Electroencephalography
C Psychological symptoms
A Characteristics, Clinical information
Sex, Age, Clinical diagnosis, subtype of diagnosis, duration of disease, comorbidity, Alcohol abuse, Performance Status, Education, vital sign, Charlson comorbidity index, American Society of Anesthesiologists classification, medication, exercise
B Biological signature and Electroencephalography
B-1 Biological signature
Analysis using perioperative (Before surgery, immediately after surgery, postoperative day1 morning, postoperative day4 - day7 morning) plasma and peripheral blood mononuclear cells
B-2 Electroencephalography
Analysis of perioperative electroencephalogram at rest using a wireless electroencephalogram sensor.
C. Psychological symptoms
C-1 delirium (diagnosis, severity)
DSM-5: The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
DRS-R-98: Delirium Rating Scale-R-98
C-2 Preoperative anxiety
HADS-A: Hospital Anxiety and Depression Scale
C-3 Cognitive function
MMSE: Mini-Mental State Examination
Subjective cognitive function (0-10)
Objective brain function (olfactory perception, palmomental reflex)
Management information
Registered date
| 2019 | Year | 12 | Month | 16 | Day |
Last modified on
| 2021 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044348
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