UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031735 |
|---|---|
| Receipt number | 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 | 2020/03/15 10:24:01 |
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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
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
jpcrm@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University. Depaertment of Surgery, Surgical Oncology and Science.
Institute
Department
Personal name
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
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
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | 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
| 2020 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036233
