UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025269 |
|---|---|
| Receipt number | R000029053 |
| Scientific Title | Japan PHarmacological Audit study of Safety and Efficacy in Real world (Phase-R) ESAS Study |
| Date of disclosure of the study information | 2016/12/14 |
| Last modified on | 2019/04/03 09:16:31 |
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Basic information
Public title
Japan PHarmacological Audit study of Safety and Efficacy in Real world (Phase-R) ESAS Study
Acronym
Phase-R ESAS Study
Scientific Title
Japan PHarmacological Audit study of Safety and Efficacy in Real world (Phase-R) ESAS Study
Scientific Title:Acronym
Phase-R ESAS Study
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in symptom scores after admission to inpatient palliative care units.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Edmonton Symptom Assessment System (ESAS) scores on admission, day 3, and day 7
Key secondary outcomes
patients' characteristics, co-morbidity, performance status, symptoms, prognostication, laboratory data, concomitant treatments
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
adult patients with cancer who admit to inpatient palliative care units.
Key exclusion criteria
Patients who cannot answer ESAS scoring due to consciousness disturbance or severe deterioration.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Kizawa |
Organization
Kobe University
Division name
Department of Palliative Medicine
Zip code
Address
7-5-1, Kusunokicho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-5111
kizawa-ysyk@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Ariyoshi |
Organization
The University of Tokyo, The Institute of Medical Science
Division name
Department of Palliative Medicine
Zip code
Address
4-6-1 Siroganedai, Minato-ku, Tokyo, Jpan
TEL
03-3443-7111
Homepage URL
k-ariyoshi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo, The Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | Month | 14 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Changes in symptom score (ESAS) after admission to inpatient palliative care units will be assessed.
Management information
Registered date
| 2016 | Year | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029053
