UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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
Email	saori.yamada@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital Gastroenterological Chemotherapy Department
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037191