UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046801 |
|---|---|
| Receipt number | R000053399 |
| Scientific Title | Prospective observational study of plasma ghrelin concentration after hematopoietic stem cell transplantation. |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/02/01 22:20:06 |
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Basic information
Public title
Prospective observational study of plasma ghrelin concentration after hematopoietic stem cell transplantation.
Acronym
Ghrelin after HCT
Scientific Title
Prospective observational study of plasma ghrelin concentration after hematopoietic stem cell transplantation.
Scientific Title:Acronym
Ghrelin after HCT
Region
| Japan |
Condition
Condition
hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between plasma ghrelin concentration and appetite loss after hematopoietic stem cell transplantation
Basic objectives2
Others
Basic objectives -Others
Physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of plasma ghrelin concentration after hematopoietic stem cell transplantation
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled for allogeneic or autologous hematopoietic stem cell transplantation
2.20 years and over
3.ECOG performance status 0 1 2
4.Patients with written consent
Key exclusion criteria
1.Patients who have difficulty communicating
2.Patients who have difficulty eating
3.Patients who have active disorder of digestive system
4.Pregnant patient
5.Patients with dementia and severe mental illness
6.Patients who underwent total gastrectomy
7.Patients that the attending physician deems ineligible
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | TSUTOMU |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Faculty of Medicine, Shimane University
Division name
Department of 3rd internal medicine
Zip code
693-8501
Address
89-1, enya-chou, izumo, shimane
TEL
0853-20-2198
ben2106t@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | TSUTOMU |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Faculty of Medicine, Shimane University
Division name
Department of 3rd internal medicine
Zip code
693-8501
Address
89-1, enya-chou, izumo, shimane
TEL
0853-20-2198
Homepage URL
ben2106t@med.shimane-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Shimane University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine.
Address
89-1, enya-chou, izumo, shimane
Tel
0853-20-2259
kenkyu@med.shimane-u.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
島根大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the patient's appetite and blood ghrelin levels over time
Management information
Registered date
| 2022 | Year | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053399
