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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024037
Receipt No. 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

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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
Email 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
Email ykentaro@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027648

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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