UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015062 |
|---|---|
| Receipt number | R000017465 |
| Scientific Title | Examination of the relationship between the relevance of a malignant tumor morbidity-polyp increase speed and LKB1 / STK11 gene mutations in Peutz-Jeghers syndrome |
| Date of disclosure of the study information | 2014/09/05 |
| Last modified on | 2020/09/08 20:09:06 |
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Basic information
Public title
Examination of the relationship between the relevance of a malignant tumor morbidity-polyp increase speed and LKB1 / STK11 gene mutations in Peutz-Jeghers syndrome
Acronym
Examination of the relationship between the relevance of a malignant tumor morbidity-polyp increase speed and LKB1 / STK11 gene mutations in Peutz-Jeghers syndrome
Scientific Title
Examination of the relationship between the relevance of a malignant tumor morbidity-polyp increase speed and LKB1 / STK11 gene mutations in Peutz-Jeghers syndrome
Scientific Title:Acronym
Examination of the relationship between the relevance of a malignant tumor morbidity-polyp increase speed and LKB1 / STK11 gene mutations in Peutz-Jeghers syndrome
Region
| Japan |
Condition
Condition
Peutz-Jeghers syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the relationship between the relevance of a malignant tumor morbidity-polyp increase speed and LKB1 / STK11 gene mutations in Peutz-Jeghers syndrome
Basic objectives2
Others
Basic objectives -Others
observation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
polyp increase speed
malignant tumor morbidity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients of Peutz-Jeghers syndrome who visit the Jichi Medical University Hospital
Key exclusion criteria
none
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Sakamoto |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
3210498
Address
3311-1 Yakushiji, Shimotsuke-Shi, Tochigi, Japan
TEL
0285-58-7348
94036hs@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Sakamoto |
Organization
Jichi Medical University
Division name
Department of Medicine, Division of Gastroenterology
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke-Shi, Tochigi, Japan
TEL
0285-58-7348
Homepage URL
94036hs@jichi.ac.jp
Sponsor or person
Institute
Department of Medicine, Division of Gastroenterology, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke-Shi, Tochigi, Japan
Tel
0285-58-7550
shien@jichi.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
自治医科大学附属病院(栃木県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 05 | 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
28
Results
We were able to identify mutations in 19 of the 28 samples, but we were unable to determine the relationship between malignancy incidence and polyp growth rate.
Results date posted
| 2020 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A case of Peutz-Jeghers syndrome in the Department of Gastroenterology, Jichi Medical University Hospital
Participant flow
Blood samples will be collected and white blood cell DNA will be extracted, and the presence or absence of LKB1/STK11 mutation and the site of mutation will be identified by direct sequencing.
Adverse events
none
Outcome measures
The rate of small intestinal polyps and the incidence of malignancy will be compared at each mutation site.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
We identify LKB1 / STK11 gene mutations in each cases.
After that, we evaluate the relationship between the relevance of a malignant tumor morbidity-polyp increase speed and these mutations prospectively.
Management information
Registered date
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017465
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