UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041764
Receipt number R000047668
Scientific Title Usefulness of ancillary staining in lymphovascular invasion evaluation of colorectal T1 cancer pathology
Date of disclosure of the study information 2021/09/11
Last modified on 2020/09/11 16:55:46

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Basic information

Public title

Usefulness of ancillary staining in lymphovascular invasion evaluation of colorectal T1 cancer pathology

Acronym

Usefulness of ancillary staining in lymphovascular invasion evaluation of colorectal T1 cancer pathology

Scientific Title

Usefulness of ancillary staining in lymphovascular invasion evaluation of colorectal T1 cancer pathology

Scientific Title:Acronym

Usefulness of ancillary staining in lymphovascular invasion evaluation of colorectal T1 cancer pathology

Region

Japan


Condition

Condition

Early colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is to compare the case of diagnosis by HE staining alone and the case of adding ancillary staining, in the lymphovascular invasion diagnosis of colorectal T1 cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensitivity to lymph node metastasis

Key secondary outcomes

Interobserver agreement among pathologists


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

T1 colorectal cancers undergoing surgical resection with lymph node dissection

Key exclusion criteria

Cases of familial adenomatous polyposis,Lynch syndrome, ulcerative colitis, synchronous invasive carcinoma

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Miyuki
Middle name
Last name Kaneshiro

Organization

Showa University Nothern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

224-8503

Address

35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan

TEL

0459497000

Email

m-kaneshiro@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Miyuki
Middle name
Last name Kaneshiro

Organization

Showa University Nothern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

224-8503

Address

35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan

TEL

0459497000

Homepage URL


Email

m-kaneshiro@med.showa-u.ac.jp


Sponsor or person

Institute

Digestive Disease Center, Shiwa University nothern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

Nothing

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

Institutional Review Board in Showa University Nothern Yokohama Hospital

Address

35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan

Tel

0459497000

Email

m-kaneshiro@med.showa-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

2021 Year 09 Month 11 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

Preinitiation

Date of protocol fixation

2020 Year 09 Month 11 Day

Date of IRB


Anticipated trial start date

2020 Year 09 Month 11 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The subjects were 200 cases of T1 colorectal cancer who underwent surgical resection at our center. Three pathologists compared the diagnosis of lymphovascular invasion with HE staining alone and with the adding ancillary staining.


Management information

Registered date

2020 Year 09 Month 11 Day

Last modified on

2020 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047668


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name