UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023220 |
|---|---|
| Receipt number | R000026745 |
| Scientific Title | Evaluation of the clinical relevance of the quantitative assay of serum intact immunoglobulins using the Hevylite chain assay in the diagnosis and disease monitoring of plasma cell dyscrasia |
| Date of disclosure of the study information | 2016/07/20 |
| Last modified on | 2019/08/22 08:57:10 |
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Basic information
Public title
Evaluation of the clinical relevance of the quantitative assay of serum intact immunoglobulins using the Hevylite chain assay in the diagnosis and disease monitoring of plasma cell dyscrasia
Acronym
Hevylite study in PCD
Scientific Title
Evaluation of the clinical relevance of the quantitative assay of serum intact immunoglobulins using the Hevylite chain assay in the diagnosis and disease monitoring of plasma cell dyscrasia
Scientific Title:Acronym
Hevylite study in PCD
Region
| Japan |
Condition
Condition
plasma cell dyscrasia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the clinical relevance of the quantitative assay of serum intact immunoglobulins using the Hevylite chain assay in the diagnosis and disease monitoring of plasma cell dyscrasia
Basic objectives2
Others
Basic objectives -Others
To measure each intact immunoglobulin at the time of diagnosis, completion of induction therapy, best response, relapse and after the completion of salvage therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The value and the ratio of HLC (Hevylite chain).
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Multiple Myeloma
Waldenstrom's Macroglobulinemia
Key exclusion criteria
We have not set up the exclusion criteria.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Shimizu |
Organization
Institute of Applied Biochmistry
Division name
Vice-president
Zip code
Address
2193-128 Aza-Minamiyama, Mitake, Mitake-Cho, Kani-Gun, Gifu
TEL
+81-574-67-5500
kshimizu@e-nagoya.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kamiya |
Organization
National Hospital Organization, Higashi Nagoya National Hospital
Division name
Division of Hematology and Oncology
Zip code
Address
5-101 Umemorizaka, Meitou-ku, Nagoya, Aichi
TEL
+81-52-801-1151
Homepage URL
yskzkmy@e-nagoya.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Higashi Nagoya National Hospital
Institute
Department
Personal name
Funding Source
Organization
Institute of Applied Biochmistry
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
新潟県立新潟がんセンター（新潟県）、群馬大学（群馬県）、京都鞍馬口医療センター（京都府）徳島県立中央病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 11 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 27 | Day |
Other
Other related information
The analysis was terminated. The paper was published.
Management information
Registered date
| 2016 | Year | 07 | Month | 19 | Day |
Last modified on
| 2019 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026745
