UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013814 |
|---|---|
| Receipt number | R000016117 |
| Scientific Title | Clinicopathological analysis of mismatch repair protein deficient colorectal cancer and its usefulness for identification of Lynch syndrome patients |
| Date of disclosure of the study information | 2014/04/25 |
| Last modified on | 2014/04/25 15:43:26 |
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Basic information
Public title
Clinicopathological analysis of mismatch repair protein deficient colorectal cancer and its usefulness for identification of Lynch syndrome patients
Acronym
MMR-deficiency in identification of colorectal cancer
Scientific Title
Clinicopathological analysis of mismatch repair protein deficient colorectal cancer and its usefulness for identification of Lynch syndrome patients
Scientific Title:Acronym
MMR-deficiency in identification of colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinicopathological analysis of mismatch repair protein deficient colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
its usefulness for identification of Lynch syndrome patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
genetic testing for Lynch syndrome
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
Invasive colorectal cancer patients who is younger than 70-years-old or meets revised Bethesda guideline
Key exclusion criteria
Patients with familial adenomatous polyposis
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakajima |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
tnakajim@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakajima |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
tnakajim@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
application
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 25 | Day |
Last modified on
| 2014 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016117
