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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038894
Receipt No. 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 2019/12/16

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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
Email 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 Immune Medicine
Zip code 1040045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 0335422511
Homepage URL
Email rsadahir@ncc.go.jp

Sponsor
Institute National Cancer Center Japan
Institute
Department

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
Email 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
2019 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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