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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031735
Receipt No. R000036233
Scientific Title A multi-institutional prospective observational study to validate the quality of pathological diagnosis by transverse slicing of semi-opened rectal specimens.
Date of disclosure of the study information 2018/03/14
Last modified on 2019/03/16

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Basic information
Public title A multi-institutional prospective observational study to validate the quality of pathological diagnosis by transverse slicing of semi-opened rectal specimens.
Acronym A multi-institutional prospective observational study to validate the quality of pathological diagnosis by transverse slicing of semi-opened rectal specimens.
Scientific Title A multi-institutional prospective observational study to validate the quality of pathological diagnosis by transverse slicing of semi-opened rectal specimens.
Scientific Title:Acronym A multi-institutional prospective observational study to validate the quality of pathological diagnosis by transverse slicing of semi-opened rectal specimens.
Region
Japan

Condition
Condition rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the quality of pathological diagnosis and measurable rate of circumferential resection margin by transverse slicing of semi-opened rectal specimens.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the measurable rate of circumferential resection margin.
Key secondary outcomes the number of examined lymph nodes.
the number of metastatic lymph nodes.

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 Rectal cancer whose lower tumor margin is within 12cm from anal verge.
The clinical stage is II or III.
Laparoscopic surgery or robotic surgery is scheduled
Key exclusion criteria The depth of invasion is T4b
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Takemasa
Organization Sapporo Medical University
Division name Depaertment of Surgery, Surgical Oncology and Science.
Zip code 060-8543
Address 291, Minami 1-jo Nishi 16-chome, Chuo-ku,,Sapporo-shi ,Hokkaidou
TEL 011-611-2111
Email jpcrm@sapmed.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Okita
Organization Sapporo Medical University
Division name Depaertment of Surgery, Surgical Oncology and Science.
Zip code 060-8543
Address 291, Minami 1-jo Nishi 16-chome, Chuo-ku,,Sapporo-shi ,Hokkaidou
TEL 011-611-2111
Homepage URL
Email jpcrm@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University. Depaertment of Surgery, Surgical Oncology and Science.
Institute
Department

Funding Source
Organization Sapporo Medical University. Depaertment of Surgery, Surgical Oncology and Science.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Sapporo medical univercity
Address 291, Minami 1-jo Nishi 16-chome, Chuo-ku,,Sapporo-shi ,Hokkaidou
Tel 011-611-2111
Email ji-rskk@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
2018 Year 03 Month 14 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 50
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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 26 Day
Last follow-up date
2018 Year 09 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Possibility of confirmation of tumor site
Whether to confirm Distal margin
Acceptance of collection of Fresh sample
Coincidence rate of CRM with preoperative MRI image
is also evaluated.

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036233

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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