UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of sarcopenia in patients with malignant lymphoma
Acronym	sarcopenia in lymphoma patients
Scientific Title	Prospective observational study of sarcopenia in patients with malignant lymphoma
Scientific Title:Acronym	sarcopenia in lymphoma patients
Region	Japan

Condition
Condition	malignant lymphoma
Classification by specialty	Hematology and clinical oncology Geriatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical significance of sarcopenia in newly-diagnosed malignant lymphoma patients.
Basic objectives2	Others
Basic objectives -Others	To assess the relationship between sarcopenia and prognosis.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in body composition(Skeltal muscle mass, Body fat mass)
Key secondary outcomes	Overall survival Progression free survival Early mortality Response rate Adverse event

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 with histologically-confirmed malignant lymphoma 2)Patients who received informed consent 3)Untreated patients 4)>=20 years old 5)Written informed consent form prior to participation in the study
Key exclusion criteria	1)Ptients with consciousness disturbance 2)Patients with severe physical dysfunction 3)Patients with severe mental disorder 4)Patients with pacemaker 5)Patients with pregnancy 6)Patients who can not stand continuously for 90 seconds 7)Patients that attending doctors judge to be inappropriate to perform this study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Tomonori Middle name Last name Nakazato
Organization	Yokohama Municipal Citizen's Hospital
Division name	Department of Hematology
Zip code	2408555
Address	56 Okazawa-cho, Hodogaya-ku, Yokohama 240-8555, Japan.
TEL	045-331-1961
Email	n-tomo@eurus.dti.ne.jp

Public contact
Name of contact person	1st name Tomonori Middle name Last name Nakazato
Organization	Yokohama Municipal Citizen's Hospital
Division name	Department of Hematology
Zip code	2408555
Address	56 Okazawa-cho, Hodogaya-ku, Yokohama 240-8555, Japan.
TEL	045-331-1961
Homepage URL
Email	n-tomo@eurus.dti.ne.jp

Sponsor
Institute	Department of Hematology Yokohama Municipal Citizen's Hospital
Institute
Department

Funding Source
Organization	Department of Hematology Yokohama Municipal Citizen's Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama Municipal Citizen's Hospital
Address	56 Okazawa-cho, Hodogaya-ku, Yokohama 240-8555, Japan
Tel	0453311961
Email	ke06-fukushima@city.yokohama.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	横浜市立市民病院血液内科

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 12 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	8
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	Terminated
Date of protocol fixation	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 03 Month 18 Day
Anticipated trial start date	2015 Year 04 Month 12 Day
Last follow-up date	2019 Year 04 Month 11 Day
Date of closure to data entry	2019 Year 04 Month 11 Day
Date trial data considered complete	2019 Year 04 Month 11 Day
Date analysis concluded	2019 Year 04 Month 30 Day

Other
Other related information	As prospected study, 1)-6) are conducted before and after 4, 8 and 12 months. 1)Body composition analysis (BIA) 2)SPPB 3)Grip strength 4)Serum albumin level 5)PS 6)BMI

Management information
Registered date	2015 Year 04 Month 12 Day
Last modified on	2020 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019768