UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020296 |
|---|---|
| Receipt number | R000023279 |
| Scientific Title | Exploratory analysis of exosomes derived from ascites and serum of patients with peritonitis carcinomatosa |
| Date of disclosure of the study information | 2015/12/24 |
| Last modified on | 2022/01/05 06:42:50 |
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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
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
sakaue_takahiko@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
