UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042584
Receipt number R000048606
Scientific Title Pharmacological risk factor for gastrointestinal bleeding after endoscopic submucosal dissection in gastric cancer patients with direct oral anticoagulants
Date of disclosure of the study information 2020/11/27
Last modified on 2023/05/29 19:40:53

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Basic information

Public title

Pharmacological risk factor for gastrointestinal bleeding after endoscopic submucosal dissection in gastric cancer patients with direct oral anticoagulants

Acronym

Pharmacological risk factor for bleeding after ESD in patients with DOAC

Scientific Title

Pharmacological risk factor for gastrointestinal bleeding after endoscopic submucosal dissection in gastric cancer patients with direct oral anticoagulants

Scientific Title:Acronym

Pharmacological risk factor for bleeding after ESD in patients with DOAC

Region

Japan


Condition

Condition

Early-stage gastric cancer patients treated with DOAC

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify a risk factor for bleeding after ESD for early-stage gastric cancer in patients treated with DOAC

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Association with plasma concentration of DOAC at trough or anti-Xa activity and incidence of bleeding after ESD for early-stage gastric cancer in patients treated with DOAC

Key secondary outcomes

(1) Effect of drug blood concentration (Xa activity) of DOAC (Tmax) on gastrointestinal bleeding after ESD for early gastrointestinal cancer in DOAC users
(2) Influence of drug-metabolizing enzyme gene polymorphisms on post-ESD gastrointestinal bleeding in early gastrointestinal cancer
(3) Effect of blood coagulation markers on gastrointestinal bleeding after ESD in early gastrointestinal cancer
(4) Extraction of endoscopic features of early gastrointestinal tract for gastrointestinal bleeding after ESD in early gastrointestinal cancer
(5) Extraction of pathological features of early gastrointestinal tract for gastrointestinal bleeding after ESD in early gastrointestinal cancer
(6) Association of CHADs score with post-ESD gastrointestinal bleeding in early gastrointestinal cancer


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

1. With consent
2. Performance status: ECOG 0 or 1
3. Early stage gastric cancer according to the treatment guideline for gastric cancer by the Japanese association of gastric cancer.
4. Over 20 years old patients treated with DOAC

Key exclusion criteria

1. No consent
2. with three kinds of anticoagulants
3. with severe diseases (heart, liver and pulmonary failure)
4. Pregnancy

Target sample size

115


Research contact person

Name of lead principal investigator

1st name Mitsushige
Middle name
Last name Sugimoto

Organization

Tokyo Medical University Hospital

Division name

Department of Gastroenterological Endoscopy

Zip code

160-8402

Address

6-1-1 Shinjuku, Shinjuku-ku,Tokyo

TEL

0333516141

Email

mura05310531@gmail.com


Public contact

Name of contact person

1st name Masaki
Middle name
Last name Masaki

Organization

National Hospital Organization Kyoto Medical Center

Division name

Department of Gastroenterology

Zip code

6128555

Address

1-1 Mukouhata-cho, Fukakusa, Fushimi-ku, Kyoto

TEL

0756419161

Homepage URL


Email

ds110674@outlook.jp


Sponsor or person

Institute

Department of Gastroenterological Endoscopy, Tokyo Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

no organization.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical University Hospital

Address

6-1-1 Shinjuku, Shinjuku-ku,Tokyo

Tel

0333516141

Email

mura05310531@gmail.com


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

2020 Year 11 Month 27 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

2020 Year 04 Month 01 Day

Date of IRB

2020 Year 04 Month 30 Day

Anticipated trial start date

2020 Year 05 Month 01 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

This research is a continuation of the previous research (UMIN000031930) conducted at Shiga University of Medical Science.


Management information

Registered date

2020 Year 11 Month 27 Day

Last modified on

2023 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048606


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name