UMIN-CTR Clinical Trial

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
Email	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
Email	issei@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatolog
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042923