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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000042584 |
Receipt No. | 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 | 2020/11/27 |
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 |
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Condition | ||
Condition | Early-stage gastric cancer patients treated with DOAC | |
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Key exclusion criteria | 1. No consent
2. with three kinds of anticoagulants 3. with severe diseases (heart, liver and pulmonary failure) 4. Pregnancy |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 | |
Registered date | File name |
Research case data | |
Registered date | File name |