UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014909 |
|---|---|
| Receipt number | 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 01:08:07 |
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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
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
mune.iguchi@gmail.com
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017341
