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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014610
Receipt No. 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

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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
Email 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
Email yamasina-ta@mc.pref.osak.jp

Sponsor
Institute Departments of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016918

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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