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
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
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
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
