UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory analysis of exosomes derived from ascites and serum of patients with peritonitis carcinomatosa
Acronym	Exploratory analysis of exosomes derived from ascites and serum of patients with peritonitis carcinomatosa
Scientific Title	Exploratory analysis of exosomes derived from ascites and serum of patients with peritonitis carcinomatosa
Scientific Title:Acronym	Exploratory analysis of exosomes derived from ascites and serum of patients with peritonitis carcinomatosa
Region	Japan

Condition
Condition	Gastrointestinal cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Exploration of predictive markers for chemoresistance and prognosis
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between exosome-derived melecules and chemoresistance/prognosis
Key secondary outcomes

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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	abdominocentesis (a period of time:-March 31 2018, an amout:20ml, times:1-several time)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who underwent abdominocentesis and/or cell-free and concentrated ascites reinfusion therapy (CART) 2. Written informed consent for participation in this study is obtained 3. > 20 years-old
Key exclusion criteria	1. Patients with the bleeding tendency 2. Patients with the infection or side vice-blood circulation road in the puncture part 3. Patients with the adhesion in a wide range of abdominal cavity or the high intestinal tract expansion 4. Patients who cannot keep rest 5. Patients who has extremely decreased whole body state 6. Patients who cannot carry out this examination safely
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Takuji Middle name Last name Torimura
Organization	Department of Medicine, Kurume University School of Medicine
Division name	Division of Gastroenterology
Zip code	830-0011
Address	67, Asahi-machi, Kurume City, Fukuoka Prefecture
TEL	0942-31-7561
Email	tori@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Takahiko Middle name Last name sakaue
Organization	Department of Medicine, Kurume University School of Medicine
Division name	Division of Gastroenterology
Zip code	830-0011
Address	67, Asahi-machi, Kurume City, Fukuoka Prefecture
TEL	0942-31-7561
Homepage URL
Email	sakaue_takahiko@med.kurume-u.ac.jp

Sponsor
Institute	Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Center, Kurume University
Address	67, Asahi-machi, Kurume City, Fukuoka Prefecture
Tel	0942-65-3749
Email	i_rinri@kurume-u.ac.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	2015 Year 12 Month 24 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	Enrolling by invitation
Date of protocol fixation	2015 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date	2015 Year 09 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	2015 Year 12 Month 21 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023279