UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of plasma cell neoplasms with PET/CT and biochemical markers of bone remodeling
Title of the study (Brief title)	Evaluation of plasma cell neoplasms with PET/CT and biochemical markers of bone remodeling
Region	Japan

Condition
Condition	plasma cell neoplasms
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate PET/CT features in the staging and management of plasma cell neoplasms
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	type of M protein Durie & Salmon staging WHO ISS staging biochemical markers of bone remodeling PET/CT imaging
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	Diagnosis
Type of intervention	Device,equipment Other
Interventions/Control_1	PET/CT imaging
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	patients with plasma cell neoplasms at Jichi Medical University
Key exclusion criteria	Patients under 20 years old Patients who cannot give their informed concent Patients in pregnancy Patients whose FBS are over 200mg/dl
Target sample size	20

Research contact person
Name of lead principal investigator	Hatano Kaoru
Organization	Jichi Medical University
Division name	Division of Hematology, Department of Medicine
Address	3311-1, Yakushiji, Shimotsuke-city, Tochigi, Japan
TEL	0285-58-7353
Email	kaorunob@jichi.ac.jp

Public contact
Name of contact person	Hatano Kaoru
Organization	Jichi Medical University
Division name	Division of Hematology, Department of Medicine
Address	3311-1, Yakushiji, Shimotsuke-city, Tochigi, Japan
TEL	0285-58-7353
Homepage URL
Email	kaorunob@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2011 Year 09 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 23 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date	2012 Year 03 Month 31 Day
Date of closure to data entry	2012 Year 03 Month 31 Day
Date trial data considered complete	2012 Year 03 Month 31 Day
Date analysis concluded	2012 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 09 Month 06 Day
Last modified on	2016 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007450