UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047457 |
|---|---|
| Receipt number | R000052025 |
| Scientific Title | Prospective observational study of Anamorelin in pancreatic cancer patients with cancer cachexia |
| Date of disclosure of the study information | 2022/04/11 |
| Last modified on | 2023/12/25 17:01:43 |
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Basic information
Public title
Prospective observational study of Anamorelin in pancreatic cancer patients with cancer cachexia
Acronym
Analysis of effect of Anamorelin for pancreatic cancer cachexia
Scientific Title
Prospective observational study of Anamorelin in pancreatic cancer patients with cancer cachexia
Scientific Title:Acronym
Analysis of effect of Anamorelin for pancreatic cancer cachexia
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of body weight and skeletal muscle mass
Key secondary outcomes
Improvement of Quality of life and Survival rate
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients appropriate for anamorelin
Patients with unresectable pancreatic cancer and relapse after surgery
Key exclusion criteria
Patients with arrhythmia, heart failure, and ischemic heart disease
Patients with uncontrolled diabetes mellitus
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | atsushi |
| Middle name | |
| Last name | yamaguchi |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Gastroenterology
Zip code
7370023
Address
Aoyamacho 3-1, Kure, Hiroshima, Japan
TEL
0823-22-3111
yamaguchi.atsushi.uc@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | reina |
| Middle name | |
| Last name | yokoo |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
IRB
Zip code
7370023
Address
Aoyamacho 3-1, Kure, Hiroshima, Japan
TEL
0823-22-3111
Homepage URL
506-chiken@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer 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 Kure Medical Center and Chugoku Cancer Center
Address
Aoyamacho 3-1, Kure, Hiroshima, Japan
Tel
0823-22-3111
yamaguchi.atsushi.uc@mail.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
| 2022 | Year | 04 | Month | 11 | 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
40
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Performing measurement of body composition and patient' QOL in 1,2,3,4 months after drug administration.
Management information
Registered date
| 2022 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052025
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/04/15 | ●エドルミズ計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/04/15 | ●チェックシート.docx |
| Research case data | |
|---|---|
| Registered date | File name |
