UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016478 |
|---|---|
| Receipt number | R000019137 |
| Scientific Title | A study on serum diamine oxidase activity and pathological analysis of duodenal mucositis in patients receiving chemotherapy |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2015/02/09 08:40:13 |
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Basic information
Public title
A study on serum diamine oxidase activity and pathological analysis of duodenal mucositis in patients receiving chemotherapy
Acronym
A study of small bowel mucosal damage by serum DAO activity and duodenal mucosa histopathology
Scientific Title
A study on serum diamine oxidase activity and pathological analysis of duodenal mucositis in patients receiving chemotherapy
Scientific Title:Acronym
A study of small bowel mucosal damage by serum DAO activity and duodenal mucosa histopathology
Region
| Japan |
Condition
Condition
Unresectable metastatic gastric cancer who received docetaxel, cisplatin and S-1 combination chemotherapy (DCS chemotherapy)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the small bowel mucosal damage caused by anticancer drugs by serum diamine oxidase and histopathology of duodenal mucosa.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum diamine oxidase and duodenal histopathology (villous atrophy)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
After inserting the oral endoscope, histological examination of the duodenal mucosa
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
| 13 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age: 13 to 79 years old
Gender: Not specified
Inpatient/outpatient: Not specified
Key exclusion criteria
1)Patients with acute abdomen
2)Patients with severe acute inflammation
3)Patients in a very bad general condition
4)Patients with suspected intestinal perforation
5)Patients having severe blood clotting defect
6)Patients with severe hepatic function
7)Patients with severe respiratory diseases or circulatory diseases
8)Gravia and possibly pregnant patients
9)Patients who do not have the capacity or intention to cooperate with the trial procedures
10)Patients, the investigator(or the subinvestigator) considers, inappropriate for entry into the trial
11)Sick or injured persons in life-threatening conditions and from whom consent for their participation in the trial
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetuji Takayama |
Organization
Health Biosciences, The University of Tokushima Graduate school
Division name
Gastroenterology and Oncology
Zip code
Address
3-18-15, kuramoto-cho, Tokushima city
TEL
088-633-7122
takayama@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jinsei Miyoshi |
Organization
Health Biosciences, The University of Tokushima Graduate school
Division name
Gastroenterology and Oncology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima city
TEL
088-633-7122
Homepage URL
jinsei03442000@gmail.com
Sponsor or person
Institute
University of Tokushima Hospital Gastroenterological medicine
Institute
Department
Personal name
Funding Source
Organization
University of Tokushima Hospital Gastroenterological medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 02 | Month | 09 | 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
| 2015 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2015 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019137
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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