UMIN-CTR Clinical Trial

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
Email	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
Email	ben2106t@med.shimane-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Shimane University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053399