UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026613 |
|---|---|
| Receipt number | R000030351 |
| Scientific Title | Study on development of prediction method of life prognosis by evaluation of oral condition of terminal cancer patient |
| Date of disclosure of the study information | 2017/03/20 |
| Last modified on | 2021/03/23 11:41:06 |
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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
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
maikoshimosato0629@hotmail.co.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030351
