UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044724 |
|---|---|
| Receipt number | R000051082 |
| Scientific Title | Prospective study of an orally-active ghrelin receptor agonist in patients with unresectable pancreatic cancer and cachexia |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2024/03/20 13:36:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective study of an orally-active ghrelin receptor agonist in patients with unresectable pancreatic cancer and cachexia
Acronym
Prospective study of an orally-active ghrelin receptor agonist in patients with unresectable pancreatic cancer and cachexia
Scientific Title
Prospective study of an orally-active ghrelin receptor agonist in patients with unresectable pancreatic cancer and cachexia
Scientific Title:Acronym
Prospective study of an orally-active ghrelin receptor agonist in patients with unresectable pancreatic cancer and cachexia
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy and tolerability of
selective agonist of the ghrelin receptor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the body weight from the baseline over the 12-week treatment period
Key secondary outcomes
1. the changes in visceral fat and subcutaneous fat
2. adverse events of selective agonist of the ghrelin receptor
3. treatment periods of selective agonist of the ghrelin receptor
4. Progression free survival of chemotherapy
5. Overall survival of chemotherapy
6. Tumor response rate
7. Disease control rate
8. Adverse events of chemotherapy
9. QOL assessment
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. the patients with chemotherapy for unresectable pancreatic cancer
2. the patients with selective ghrelin receptor agonist for cachexia
3. age>= 20 years
Key exclusion criteria
1. Judgement by doctors
2. Off label use for selective ghrelin receptor agonist
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Nakai |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku, Tokyo
TEL
03-3815-5411
ynakai-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
suzutatsu86@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
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
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1, Hongo Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.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
| 2021 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051082
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
