UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032619 |
|---|---|
| Receipt number | R000037191 |
| Scientific Title | A pilot study to verify the optimal condition under Cell-free and Concentrated Ascites Reinfusion Therapy (CART) to deal with huge amount of the malignant ascites |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2022/06/06 16:46:30 |
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Basic information
Public title
A pilot study to verify the optimal condition under Cell-free and Concentrated Ascites Reinfusion Therapy
(CART) to deal with huge amount of the malignant ascites
Acronym
A pilot study to verify the optimal condition under Cell-free and Concentrated Ascites Reinfusion Therapy
(CART) to deal with huge amount of the malignant ascites
Scientific Title
A pilot study to verify the optimal condition under Cell-free and Concentrated Ascites Reinfusion Therapy
(CART) to deal with huge amount of the malignant ascites
Scientific Title:Acronym
A pilot study to verify the optimal condition under Cell-free and Concentrated Ascites Reinfusion Therapy
(CART) to deal with huge amount of the malignant ascites
Region
| Japan |
Condition
Condition
gastrointestinal cancer, gynecologic cancer
Classification by specialty
| Gastroenterology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the optimal condition under Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
Basic objectives2
Others
Basic objectives -Others
pilot study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Part1
primary endpoint:rate of variability of all examinations
Part2
primary endpoint:highest rate of variability
Part3
primary endpoint:recovery rate of Alb
Key secondary outcomes
Part2 secondary endpoints:another rate of variability
Part3 secondary endpoints:processing time,comparison of each examinations
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
patients who have massive malignant ascites and want simple puncture over 1L (part1), over 2L(part2,3)
Interventions/Control_2
patients who have massive malignant ascites and want simple puncture over 1L (part1), over 2L(part2,3)
Interventions/Control_3
patients who have massive malignant ascites and want simple puncture over 1L (part1), over 2L(part2,3)
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 advanced gastrointestinal cancer or gynecological cancer
2 patients who have massive ascites
3 An age of over 20
4 PS ECOG performance status score 0 to 4
5 Written informed consent must be taken by patients
Key exclusion criteria
1)patients who do not have sufficient ascites
2)Patients who are judged inappropriate for the entry into this study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi Ichimura |
| Middle name | |
| Last name | Takashi Ichimura |
Organization
Cancer Institute Hospital
Division name
Gastroenterological Chemotherapy Department
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
TEL
03-3520-0111
takashi.ichimura@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Saori Yamada |
| Middle name | |
| Last name | Saori Yamada |
Organization
Cancer Institute Hospital
Division name
Gastroenterological Chemotherapy Department
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
TEL
03-3520-0111
Homepage URL
saori.yamada@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital
Gastroenterological Chemotherapy Department
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital
Gastroenterological Chemotherapy Department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Asahi Kasei Medical
IRB Contact (For public release)
Organization
med.shinsa@jfcr.or.jp
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
Tel
03-3520-0111
med.shinsa@jfcr.or.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
| 2018 | Year | 05 | Month | 31 | 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
| 2018 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 17 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037191
