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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032619
Receipt No. 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 2021/05/19

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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 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 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
2018 Year 05 Month 17 Day
Last modified on
2021 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037191

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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