UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010348 |
|---|---|
| Receipt number | R000012113 |
| Scientific Title | The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma |
| Date of disclosure of the study information | 2013/03/28 |
| Last modified on | 2019/10/04 07:11:32 |
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Basic information
Public title
The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma
Acronym
The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma
Scientific Title
The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma
Scientific Title:Acronym
The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between fatigue and reactivation of HHV-6 in the multiple myeloma patients who receive chemotherapy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the correlation between fatigue and several markers that represent fatigue, such as the level of HHV6 DNA in saliva, the level of HHV7 DNA in saliva, fatigue factor, fatigue recovery factor, and inflammatory cytokines.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
harvest of saliva, and blood test.
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 multiple myeloma
2. To receive chemotherapy
3. ECOG PS = 0-2
4. The hemoglobin level >= a facilities standard value
5. To answer the questions to evaluate the degree of fatigue.
6. Harvest the adequate volume of saliva
Key exclusion criteria
1. Severe phycological disorder
2. Infection of HIV, HTLV=1, HBV, HCV
3. Congenital immunodeficiency
4. Severe complications, such as hypertension, congestive heart failure, coronary artery disease, liver cirrhosis, diabetes mellitus, and respiratory failure.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Suzuki |
Organization
The Jikei University School of Medicine
Division name
Devision of Clinical Oncology/ Hematology
Zip code
105-8567
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo.
TEL
03-3433-1111
kaz-suzuki@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhito |
| Middle name | |
| Last name | Suzuki |
Organization
The Jikei University School of Medicine
Division name
Devision of Clinical Oncology/ Hematology
Zip code
105-8567
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
kaz-suzuki@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
The Jikei University School of Medicine
Address
3-25-8 Nishi-sihmbashi, Minato-ku, Tokyo
Tel
03-3433-1111
kaz-suzuki@jikei.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 28 | Day |
Last modified on
| 2019 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012113
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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