UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047993 |
|---|---|
| Receipt number | R000054709 |
| Scientific Title | A prospective observational study of the national survey of Cowden syndrome/PTEN Hamartoma Tumor Syndrome (PHTS) |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/06/08 18:53:47 |
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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
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
okamoto.koichi@tokushima-u.ac.jp
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054709
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
