UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023220
Receipt No. 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 2019/03/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yskzkmy@e-nagoya.hosp.go.jp

Sponsor
Institute National Hospital Organization, Higashi Nagoya National Hospital
Institute
Department

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
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 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 submitted.

Management information
Registered date
2016 Year 07 Month 19 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026745

Research Plan
Registered date File name
2017/02/06 161018_Hevylite 研究実施計画書_Ver.3.0.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.