UMIN-CTR Clinical Trial

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

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
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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	300

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
Institute	Department of Gastroenterological Endoscopy, Tokyo Medical University Hospital
Institute
Department

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
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Results Delayed
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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	2020 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048606

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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