UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025382 |
|---|---|
| Receipt number | R000029223 |
| Scientific Title | The optimal ultrafiltration method in cell-free and concentrated ascites reinfusion therapy |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2018/09/03 10:07:05 |
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Basic information
Public title
The optimal ultrafiltration method in cell-free and concentrated ascites reinfusion therapy
Acronym
The optimal ultra filtration method in CART
Scientific Title
The optimal ultrafiltration method in cell-free and concentrated ascites reinfusion therapy
Scientific Title:Acronym
The optimal ultra filtration method in CART
Region
| Japan |
Condition
Condition
Patients with refractory cancerous ascites
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the optimal ultrafiltration method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The time to reach the set pressure (TMP500mmHg)
Key secondary outcomes
1. The serial change of transmembrane pressure and ascites weight
2. Analysis of the original ascites and the filtered ascites
3. Analysis of the filter
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
concentrated ascites reinfusion therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patients with refractory cancerous as cites who are judged as the indication of CART
2. The first CART for the patient
3. The patients who can recognize the study and express the agreement by the document.
Key exclusion criteria
1. Patients with ascites contaminated by endotoxin
2. Severe immunocompromized patients
3. Patients who have peritoneo-venous shunt
4. Patients who have transjugular intrahepatic portosystemic shunt
5. Infection; Syphilis HBs antigen HBc antibody HCV HIV01,2 HTLV1
6. Patients who are judged as the inappropriate for this study by the doctor.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Midori Hasegawa |
Organization
Fujita Health University School of Medicine
Division name
Department of Nephrology
Zip code
Address
1-98 Dengakugakubo Kutsukakecho Toyoakeshi Aichi
TEL
0562-93-9245
mhase@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Hasegawa |
Organization
Fujita Health University School of Medicine
Division name
Department of Nephrology
Zip code
Address
1-98 Dengakugakubo Kutsukakecho Toyoakeshi Aichi
TEL
0562-93-9245
Homepage URL
mhase@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
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
Address
Tel
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
| 2017 | Year | 01 | Month | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 22 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029223
