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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016478
Receipt No. 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

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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
Email 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
Email jinsei03442000@gmail.com

Sponsor
Institute University of Tokushima Hospital Gastroenterological medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019137

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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