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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031930
Receipt No. R000036457
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 2018/03/28
Last modified on 2018/03/27

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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
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

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
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 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsushige Sugimoto
Organization Shiga University of Medical Science Hospital
Division name Division of Digestive Endoscopy
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, 520-2192
TEL 077-548-2618
Email sugimo@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsushige Sugimoto
Organization Shiga University of Medical Science Hospital
Division name Division of Digestive Endoscopy
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, 520-2192
TEL 077-548-2618
Homepage URL
Email sugimo@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization Shiga University of Medical Science Hospital
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
Address
Tel
Email

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
2018 Year 03 Month 28 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
2018 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2018 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036457

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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