UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043922
Receipt number R000050152
Scientific Title Clinicopathological differences between small and large T1 colorectal cancer
Date of disclosure of the study information 2021/04/16
Last modified on 2021/04/14 13:19:47

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Basic information

Public title

Clinicopathological differences between small and large T1 colorectal cancer

Acronym

Clinicopathological differences between small and large T1 colorectal cancer

Scientific Title

Clinicopathological differences between small and large T1 colorectal cancer

Scientific Title:Acronym

Clinicopathological differences between small and large T1 colorectal cancer

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 clinicopathological features of small and large T1 colorectal cancers.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinicopathological features included patient age, sex, initial treatment, tumor size, morphology, invasion depth, histological grade, lymphatic invasion, vascular invasion, tumor budding, and lymph node metastasis.

Key secondary outcomes



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 surgicaland endoscopic resection

Key exclusion criteria

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

Target sample size

1150


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Takashina

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

224-8503

Address

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

TEL

0459497000

Email

y_takashina2011@yahoo.co.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Takashina

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

224-8503

Address

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

TEL

0459497000

Homepage URL


Email

y_takashina2011@yahoo.co.jp


Sponsor or person

Institute

Digestive Disease Center, Showa University Northern 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 Northern Yokohama Hospital,

Address

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

Tel

0459497000

Email

y_takashina2011@yahoo.co.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

昭和大学横浜市北部病院 消化器センター


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 16 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

1150

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

Completed

Date of protocol fixation

2019 Year 12 Month 18 Day

Date of IRB

2020 Year 01 Month 07 Day

Anticipated trial start date

2020 Year 01 Month 07 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The subjects were 1,152 patients with colorectal T1 cancer who underwent endoscopic or surgical resection at our center. Of these, 116 were small T1 cancers (<10mm) and 1036 were large T1 cancers (>10mm). The clinicopathological characteristics (age, sex, tumor size, gross type, SM invasiveness, histological type, lymphatic invasion, venous invasion, grouping, lymph node metastasis, and initial treatment) were compared between the two groups.


Management information

Registered date

2021 Year 04 Month 14 Day

Last modified on

2021 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050152


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name