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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042923


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name