UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045764 |
|---|---|
| Receipt number | R000052249 |
| Scientific Title | Observational study on physical properties of drained malignant ascites |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2023/04/23 13:12:49 |
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Basic information
Public title
Observational study on physical properties of drained malignant ascites
Acronym
Observational study on physical properties of drained malignant ascites
Scientific Title
Observational study on physical properties of drained malignant ascites
Scientific Title:Acronym
Observational study on physical properties of drained malignant ascites
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the physical properties of the drained malignant ascites
Basic objectives2
Others
Basic objectives -Others
To clarify the the viscosity of the drained malignant ascites
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of the viscosity of the malignant ascites
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) the patients over the age of 20
2) Outpatient or hospitalized patient of National Cancer Center Hospital (Japan)
3) Diagnosed as the unresectable malignant tumor by pathological or imaging findings.
4) The attending doctor determined that the malignant ascites was required percutaneous drainage clinically.
5) The expected amount of ascites drainage is considered to be 500 ml or more.
Key exclusion criteria
1) Patients judged by the principal investigator to be inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
shijoka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Maehara |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
kmaehara@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
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
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
kmaehara@ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 15 | 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
30
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the physical properties of the drained malignant ascites
Management information
Registered date
| 2021 | Year | 10 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052249
