UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014610 |
|---|---|
| Receipt number | R000016918 |
| Scientific Title | The efficacy and safety of Double-balloon enteroscopy and Capsule endoscopy for primary intestinal follicular lymphoma |
| Date of disclosure of the study information | 2014/07/30 |
| Last modified on | 2015/08/25 05:25:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy and safety of Double-balloon enteroscopy and Capsule endoscopy for primary intestinal follicular lymphoma
Acronym
The efficacy and safety of DBE and CE for FL
Scientific Title
The efficacy and safety of Double-balloon enteroscopy and Capsule endoscopy for primary intestinal follicular lymphoma
Scientific Title:Acronym
The efficacy and safety of DBE and CE for FL
Region
| Japan |
Condition
Condition
primary intestinal follicular lymphoma
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of Double-balloon enteroscopy and Capsule endoscopy for primary intestinal follicular lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate of Double-balloon enteroscopy and Capsule endoscopy for diagnosis of primary intestinal follicular lymphoma
Key secondary outcomes
Base
Study type
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
The diagnosis was based on CE, morphological and immunophenotypic
analysis of biopsy specimens obtained from DBE.
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 aged over 20 years
2)patients give their written informed consent to participate.
Key exclusion criteria
1)Lugano International classification stageII2,IV
2)stenosis of small bowel
3) patients whom a researcher judged to be inappropriate as a subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ishihara Ryu |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
Division name
Departments of Gastrointestinal Oncology
Zip code
Address
3-3 Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
yamasina-ta@mc.pref.osak.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamashina Takeshi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
Division name
Departments of Gastrointestinal Oncology
Zip code
Address
3-3 Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan
TEL
06-6972-1181
Homepage URL
yamasina-ta@mc.pref.osak.jp
Sponsor or person
Institute
Departments of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 07 | Month | 30 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 10 | 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
| 2014 | Year | 07 | Month | 22 | Day |
Last modified on
| 2015 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016918
