UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037652 |
|---|---|
| Receipt number | R000042923 |
| Scientific Title | The retrospective study to examine the usefulness of IMP3 immunostaining for tissue diagnosis and the diagnosis of invasion depth in colorectal neoplasm |
| Date of disclosure of the study information | 2019/09/30 |
| Last modified on | 2021/08/10 17:15:02 |
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Basic information
Public title
The retrospective study to examine the usefulness of IMP3 immunostaining for tissue diagnosis and the diagnosis of invasion depth in colorectal neoplasm
Acronym
The retrospective study to examine the usefulness of IMP3 immunostaining for tissue diagnosis and the diagnosis of invasion depth in colorectal neoplasm
Scientific Title
The retrospective study to examine the usefulness of IMP3 immunostaining for tissue diagnosis and the diagnosis of invasion depth in colorectal neoplasm
Scientific Title:Acronym
The retrospective study to examine the usefulness of IMP3 immunostaining for tissue diagnosis and the diagnosis of invasion depth in colorectal neoplasm
Region
| Japan |
Condition
Condition
Colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of IMP3 immunostaining for tissue diagnosis and the diagnosis of invasion depth in colorectal neoplasm
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tissue diagnostic accuracy rate and invasion depth accuracy rate of IMP3 immunostaining
Key secondary outcomes
Sensitivity, specificity, positive predictive value, and negative predictive value for tissue diagnosis in IMP3 immunostaining.
Sensitivity, specificity, positive predictive value, and negative predictive value for the diagnosis of invasion depth in IMP3 immunostaining.
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
Patients who are over 20 years old.
Patients who has undergone endoscopic or surgical resection in colorectal tumor and are capable of pathological evaluation.
Key exclusion criteria
Patients without image data and pathological specimens that can be fully evaluated.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-741-2172
tyamamu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Issei |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-741-2172
Homepage URL
issei@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Gastroenterology and Hepatolog
Institute
Department
Personal name
Funding Source
Organization
None
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
Nagoya University Hospital Ethics Review Committee
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-741-2172
tyamamu@med.nagoya-u.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
| 2019 | Year | 09 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this prospective observation study is to investigate the usefulness of IMP3 immunostaining for tissue diagnosis and the diagnosis of invasion depth in colorectal neoplasm.
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2021 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042923
