UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024037 |
|---|---|
| Receipt number | R000027648 |
| Scientific Title | Universal screening for all newly diagnosed colorectal cancer patients to identify Lynch syndrome |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/03/20 07:43:40 |
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Basic information
Public title
Universal screening for all newly diagnosed colorectal cancer patients to identify Lynch syndrome
Acronym
Universal screening to identify Lynch syndrome
Scientific Title
Universal screening for all newly diagnosed colorectal cancer patients to identify Lynch syndrome
Scientific Title:Acronym
Universal screening to identify Lynch syndrome
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify Lynch syndrome patients who will be missed by the Amsterdam criteria or the revised Bethesda guidelines.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of Lynch syndrome patients who meet the Amsterdam criteria and the Bethesda guidelines to all Lynch patients
Key secondary outcomes
Sensitivity of MSI and immunostaining to identify Lynch syndrome
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Colorectal cancer patients treated at our hospital
Key exclusion criteria
Patients under 18 years old
Patients whose cancer tissue is not available for MSI analysis and immunostaining
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamashita |
Organization
Sapporo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
0608543
Address
S1W16, Chuo-ku, Sapporo
TEL
011-611-2111
ykentaro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamashita |
Organization
Sapporo Medical Universtiy
Division name
Department of Gastroeterology and Hepatology
Zip code
0608543
Address
S1W16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
ykentaro@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical 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
Sapporo Medical University
Address
S1W16, Chuo-ku, Sapporo
Tel
0116112111
ykentaro@sapmed.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
| 2016 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027648
