UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010114 |
|---|---|
| Receipt number | R000011853 |
| Scientific Title | Exploration of the diagnositic system of Lynch syndrome |
| Date of disclosure of the study information | 2013/02/26 |
| Last modified on | 2014/04/01 23:11:06 |
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Basic information
Public title
Exploration of the diagnositic system of Lynch syndrome
Acronym
Exploration of the diagnositic system of Lynch syndrome
Scientific Title
Exploration of the diagnositic system of Lynch syndrome
Scientific Title:Acronym
Exploration of the diagnositic system of Lynch syndrome
Region
| Japan |
Condition
Condition
Lynch syndrome
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Surgery in general |
| Gastrointestinal surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the diagnostic system of Lynch syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy of immunohistochemical testing
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who were diagnosed Lynch syndrome
Key exclusion criteria
none
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Toyoda |
Organization
Kobe University Hospital
Division name
Medical oncology / Hematology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Hospital
Division name
Medical oncology / Hematology
Zip code
Address
TEL
078-382-5820
Homepage URL
masanoritoyo@hotmail.co.jp
Sponsor or person
Institute
Kobe University Hospital
Medical oncology / Hematology
Institute
Department
Personal name
Funding Source
Organization
fellowship of Second dept. of internal medicine, Kobe University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Plan to examine about twenty tissue samples of Lynch syndrome by using immunohistochemical testing
Management information
Registered date
| 2013 | Year | 02 | Month | 25 | Day |
Last modified on
| 2014 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011853
