UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of the national survey of Cowden syndrome/PTEN Hamartoma Tumor Syndrome (PHTS)
Acronym	A prospective observational study of the national survey of Cowden syndrome/PTEN Hamartoma Tumor Syndrome (PHTS)
Scientific Title	A prospective observational study of the national survey of Cowden syndrome/PTEN Hamartoma Tumor Syndrome (PHTS)
Scientific Title:Acronym	A prospective observational study of the national survey of Cowden syndrome/PTEN Hamartoma Tumor Syndrome (PHTS)
Region	Japan

Condition
Condition	Cowden syndrome/PTEN Hamartoma Tumor Syndrome (PHTS)
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To establish a registry and clarify the prevalence, manifestation, complication, and other characteristics of Cowden syndrome/PHTS patients in Japan.
Basic objectives2	Others
Basic objectives -Others	Frequency of carcinogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify prevalence, manifestation, complication, characteristics, and others of Cowden syndrome/PHTS patients in Japan.
Key secondary outcomes	Frequency of carcinogenesis

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Cowden syndrome/PHTS patients 2. Age 16 or over
Key exclusion criteria	The patients who do not give informed consent.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tetsuji Middle name Last name Takayama
Organization	Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Gastroenterology and Oncology
Zip code	770-8503
Address	3-18-15, Kuramoto-cho, Tokushima
TEL	0886337124
Email	takayama@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Okamoto
Organization	Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University
Division name	Gastroenterology and Oncology
Zip code	770-8503
Address	3-18-15, Kuramoto-cho, Tokushima
TEL	0886337124
Homepage URL
Email	okamoto.koichi@tokushima-u.ac.jp

Sponsor
Institute	The Japanese Society for Hereditary Tumors and Research on rare and intractable disease, Health and Labor Sciences Research Grants from the Ministry of Health, Labour and Welfare of Japan.
Institute
Department

Funding Source
Organization	The Japanese Society for Hereditary Tumors and Research on rare and intractable disease, Health and Labor Sciences Research Grants from the Ministry of Health, Labour and Welfare of Japan.
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	Department of Gastroenterology and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School
Address	3-18-15, Kuramoto-cho, Tokushima
Tel	0886337124
Email	takayama@tokushima-u.ac.jp

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	2022 Year 07 Month 01 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	Open public recruiting
Date of protocol fixation	2022 Year 01 Month 19 Day
Date of IRB	2022 Year 03 Month 01 Day
Anticipated trial start date	2022 Year 03 Month 01 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A prospective observation study

Management information
Registered date	2022 Year 06 Month 08 Day
Last modified on	2022 Year 06 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054709