UMIN-CTR Clinical Trial

Basic information
Public title	Multiple endocrine neoplasia type 1: an observational study on the frequency of imaging tests used for diagnosis and follow-up of MEN1.
Acronym	Observational study of MEN1.
Scientific Title	Multiple endocrine neoplasia type 1: an observational study on the frequency of imaging tests used for diagnosis and follow-up of MEN1.
Scientific Title:Acronym	Observational study of MEN1.
Region	Japan

Condition
Condition	Multiple endocrine neoplasia type 1
Classification by specialty	Medicine in general Radiology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate what imaging tests are performed at each lesion site and with what frequency in patients diagnosed and followed with MEN1 at Tohoku University Hospital.
Basic objectives2	Others
Basic objectives -Others	Find out the frequency of imaging tests
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of imaging tests
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	20 years-old <
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Diagnosis of MEN1 (2) Any stage or disease stage (3) Any age at the time of registration (4) Patients undergoing imaging tests, treatment and follow-up at this hospital
Key exclusion criteria	Those that have been seen only once and have not been followed up in this hospital
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Naoko Middle name Last name Mori
Organization	Tohoku University
Division name	Department of Diagnostic Radiology
Zip code	9808574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	0227177312
Email	naokomoroi7127@gmail.com

Public contact
Name of contact person	1st name Naoko Middle name Last name Mori
Organization	Tohoku University
Division name	Department of Diagnostic Radiology
Zip code	9808574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	0227177312
Homepage URL
Email	naokomoroi7127@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tohoku University
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel	0227177312
Email	naokomori7127@gmail.com

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	2025 Year 03 Month 20 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	Preinitiation
Date of protocol fixation	2022 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 10 Day
Last follow-up date	2027 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2022 Year 04 Month 27 Day
Last modified on	2022 Year 04 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054285