UMIN-CTR Clinical Trial

Basic information
Public title	Study on development of prediction method of life prognosis by evaluation of oral condition of terminal cancer patient
Acronym	Life prognostic prediction method for terminal cancer patients
Scientific Title	Study on development of prediction method of life prognosis by evaluation of oral condition of terminal cancer patient
Scientific Title:Acronym	Life prognostic prediction method for terminal cancer patients
Region	Japan

Condition
Condition	cancer in terminal stage
Classification by specialty	Medicine in general Gastroenterology Geriatrics Dental medicine Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the relationship between the evaluation of oral condition and life expectancy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of days untill death
Key secondary outcomes	Oral condition (A)Oral mucosal wetness (B)Candida fungi quantity and fungus species

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who had been admitted to palliative care beds and consent of oral care round
Key exclusion criteria	Patiants whose cancer lesion is present at the measurement site Patients intended for respite purposes or symptom mitigation purposes, temporary hospitalization for other reasons
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Maiko Middle name Last name Shimosato
Organization	National Hospital Organization Kyoto Medical Center
Division name	Clinical Reserch Institute
Zip code	612-8555
Address	1-1 Mukaihatacho Fukakusa Fushimiku Kyoto 612-8555
TEL	075-641-9161
Email	maikoshimosato0629@hotmail.co.jp

Public contact
Name of contact person	1st name Maiko Middle name Last name Shimosato
Organization	National Hospital Organization Kyoto Medical Center
Division name	Clinical Reserch Institute
Zip code	612-8555
Address	1-1 Mukaihatacho Fukakusa Fushimiku Kyoto 612-8555
TEL	075-641-9161
Homepage URL
Email	maikoshimosato0629@hotmail.co.jp

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyoto Medical Center
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	National Hospital Organization Kyoto Medical Center
Address	1-1 Mukaihatacho Fukakusa Fushimiku Kyoto 612-8555
Tel	075-641-9161
Email	syomuhan@kyotolan.hosp.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	2017 Year 03 Month 20 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	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 21 Day
Date of IRB	2016 Year 12 Month 19 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	no special instruction

Management information
Registered date	2017 Year 03 Month 20 Day
Last modified on	2021 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030351