UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021702 |
|---|---|
| Receipt number | R000025038 |
| Scientific Title | A Multicentral prospective observation study of venous thromboembolism in patient after gastric cancer surgery. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2022/05/11 20:41:25 |
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Basic information
Public title
A Multicentral prospective observation study of venous thromboembolism in patient after gastric cancer surgery.
Acronym
An observation study of venous thromboembolism in patient after gastric cancer surgery (SHISA1601)
Scientific Title
A Multicentral prospective observation study of venous thromboembolism in patient after gastric cancer surgery.
Scientific Title:Acronym
An observation study of venous thromboembolism in patient after gastric cancer surgery (SHISA1601)
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence of venous thromboembolism (VTE) by comparison between related facilities and to find the VTE markers for early diagnosis in patients after gastric cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Examination of relationship between venous thromboembolism (VTE) and VTE prevention after gastric cancer surgery
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) histologically diagnosed as gastric cancer
2) planned to receive curative operation
3)ECOG Performance Status Scale: 0-2
4) 20 years old or more at registration
5) Patients who have given oral informed consent to take part in the study after detailed explanation of the study prior to enrollment
Key exclusion criteria
1)Past history of venous thromboembolism till the scheduled date of surgery
2)Severe renal dysfunction (30mL/min >= CCr)
3)Administration of anticoagulant and / or antiplatelet agent before operation
4)Any other condition that, in the investigator's opinion, places the subject at undue risk by participating in the study
Target sample size
1120
Research contact person
Name of lead principal investigator
| 1st name | Masaji |
| Middle name | |
| Last name | Tani |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Tsukinowa-cho, Seta, Otsu, 5202192, JAPAN
TEL
077-548-2238
mtani@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Kaida |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Tsukinowa-cho, Seta, Otsu, 5202192, JAPAN
TEL
077-548-2238
Homepage URL
kaida@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Surgery, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
none
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
Shiga University of Medical Science
Address
Tsukinowa-cho, Seta, Otsu, Shiga
Tel
077-548-2238
kaida@belle.shiga-med.ac.jp
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
滋賀医科大学医学部附属病院（滋賀県）、草津総合病院（滋賀県）、ベルランド総合病院（大阪府）、長浜赤十字病院（滋賀県）、奈良市立病院（奈良県）、小松市民病院（石川県）、新古賀病院（福岡県）、赤穂市民病院（兵庫県）、古賀病院21（兵庫県）、JCHO滋賀病院（滋賀県）、畷生会脳外科病院（大阪府）、日野記念病院（滋賀県）、豊郷病院（滋賀県）、甲南病院（滋賀県）、野洲病院（滋賀県）、湖東記念病院（滋賀県）、琵琶湖大橋病院（滋賀県）、喜馬病院（大阪府）、西京都病院（京都府）、マキノ病院（滋賀県）、紫香楽病院（滋賀県）、長浜市立湖北病院（滋賀県）、生田病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Observation study
Object recruitment : All patients who admitted in Shiga University of Medical Science or other related facility and meet the selection criteria from June 1,2016 to May 28, 2018.
Parameter measurement:
The following results of blood test on the preoperative day and the postoperative day 7:
complete blood count(CBC), Albumin, ALT, AST, T-Bil, Cre, PT, APTT, D-dimer
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025038
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
