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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014909
Receipt No. R000017341
Scientific Title Evaluation of chemotherapy induced small intestinal injury by capsule endoscopy
Date of disclosure of the study information 2014/09/01
Last modified on 2014/10/15

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Basic information
Public title Evaluation of chemotherapy induced small intestinal injury by capsule endoscopy
Acronym Evaluation of chemothelapy induced small intestinal injury by capsule endoscopy
Scientific Title Evaluation of chemotherapy induced small intestinal injury by capsule endoscopy
Scientific Title:Acronym Evaluation of chemothelapy induced small intestinal injury by capsule endoscopy
Region
Japan

Condition
Condition Esophageal Cancer/Gastric Cancer/Colorectal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We examine the influence of the anticancer agent in the small intestine using a capsule endoscope.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the small intestinal injuries induced by chemothelapy
Key secondary outcomes 1.Location and From of small intestinal injuries.
2.We compare the change of Plasma
diamioxidase(DAO) activities and calprotectin before and after chemotherapy.
3.We check a correlation with Lewis score in DAO and calprotectin

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 capsule endoscopy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. The subjects who agree to participate in this study by written informed consent.
2. The subject who receive chemothetapy.
3. The subject who received patency capsule endoscopy and are proved patency of gastrointestinal tract.
Key exclusion criteria 1. Dysphagia
2. Poor general cindition.
3. The subjects who can not prove patency of gastrointestinal tract.
4. The subject with allergic reaction barium examination.
5. The subject who have a pacemaker and other medical equipment.
6. The subject who do not agree agreement for surgical removal of
7. The patient who participates in another study which may affect this study.
8. The subject who are judged to be inappropriate for this study by doctors conducting this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Osaka Medical College
Division name Second Dep of Internal Medicine
Zip code
Address 2-7,Daigakumachi,Takatuki-city,Osaka,Japan
TEL 072-683-1221
Email higuchi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Munetaka Iguchi
Organization Osaka Medical College
Division name Second Dep of Internal Medicine
Zip code
Address 2-7,Daigakumachi,Takatuki-city,Osaka,Japan
TEL 072-683-1221
Homepage URL
Email mune.iguchi@gmail.com

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2014 Year 09 Month 01 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
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 07 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2021 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 20 Day
Last modified on
2014 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017341

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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