UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017109
Receipt number 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 2020/01/04 01:04:04

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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

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 or person

Institute

Department of Hematology
Yokohama Municipal Citizen's Hospital

Institute

Department

Personal name



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

Value
https://center6.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