UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Crowned dens syndrome: multicenter retrospective case series
Title of the study (Brief title)	Crowned dens syndrome: multicenter retrospective case series
Region	Japan

Condition
Condition	Crowned dens syndrome (CDS)
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the present study is to report our experience with and describe the clinical features of crowned dens syndrome in Japan.
Basic objectives2	Others
Basic objectives -Others	Clinical feature
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of the crowned dens syndrome (CDS); Proportion of the patients who were diagnosed with CDS within one day; and Clinical features of CDS
Key secondary outcomes	Time required for resolution; Causes of delayed diagnosis; Features of cases in which lumbar puncture was performed; Features of inpatient cases; and Features of misdiagnosed cases

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	Adult patients who had neck pain and in whom radiography revealed calcifications around the dens.
Key exclusion criteria	No diagnosis of CDS in the medical records.
Target sample size	40

Research contact person
Name of lead principal investigator	Hiroki Isono
Organization	Tsukuba University Hospital Mito Medical Center
Division name	General internal medicine
Address	3-2-7 Miyamachi, Mito, Ibaraki 310-0015, Japan.
TEL	029-231-2371
Email	isono-tuk@umin.ac.jp

Public contact
Name of contact person	Hiroki Isono
Organization	Tsukuba University Hospital Mito Medical Center
Division name	General internal medicine
Address	3-2-7 Miyamachi, Mito, Ibaraki 310-0015, Japan.
TEL	029-231-2371
Homepage URL
Email	isono-tuk@umin.ac.jp

Sponsor
Institute	Tsukuba University Hospital Mito Medical Center
Institute
Department

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)

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

水戸協同病院(茨城県) Tsukuba University Hospital Mito Medical Center(Ibaraki) 湘南鎌倉総合病院(神奈川県)　Shonankamakura General Hospital(Kanagawa) 明石医療センター(兵庫県)　Akashi Medical Center (Hyogo) 練馬光が丘病院(東京都)　 Nerima Hikarigaoka Hospital(Tokyo) 東京ベイ浦安市川医療センター(千葉県) Tokyobay UrayasuIchikawa Medical Center(Chiba) 飯塚病院(福岡県)　Aso Iizuka Hospital (Fukuoka) 筑波メディカルセンター病院(茨城県) Tsukuba Medical Center Hospital (Ibaraki) 亀田総合病院(千葉県) Kameda Medical Center (Chiba)

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 15 Day
Anticipated trial start date	2015 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2016 Year 12 Month 30 Day

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

Management information
Registered date	2015 Year 07 Month 21 Day
Last modified on	2016 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021268