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
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
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
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
