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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017109
Receipt No. R000019768
Scientific Title Prospective observational study of sarcopenia in patients with malignant lymphoma
Date of disclosure of the study information 2015/04/12
Last modified on 2015/04/12

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

Public contact
1st name of contact person
1st name
Middle name
Last name Tomonori Nakazato
Organization Yokohama Municipal Citizen's Hospital
Division name Department of Hematology
Zip code
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
Address
Tel
Email

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
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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
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
2015 Year 04 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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