UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027730
Receipt No. R000031773
Scientific Title Investigation of clinical utility of flow cytometry using endoscopically biopsied specimen for diagnosis of gastrointestinal lymphoma
Date of disclosure of the study information 2017/06/12
Last modified on 2019/09/02

* 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 Investigation of clinical utility of flow cytometry using endoscopically biopsied specimen for diagnosis of gastrointestinal lymphoma
Acronym Flow cytometry for gastrointestinal lymphoma
Scientific Title Investigation of clinical utility of flow cytometry using endoscopically biopsied specimen for diagnosis of gastrointestinal lymphoma
Scientific Title:Acronym Flow cytometry for gastrointestinal lymphoma
Region
Japan

Condition
Condition gastrointestinal lymphoma
Classification by specialty
Medicine in general Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigating clinical utility of flow cytometry using endoscopically biopsied specimen for diagnosis of gastrointestinal lymphoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes i) evaluation of the number of lymphocytes that can be read by flow cytometry and ii) whether those lymphocytes can be diagnosed as neoplastic (lymphoma) or not
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients with gastrointestinal lymphoma and who undergo endoscopic biopsy
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaya Iwamuro
Organization Okayama University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7218
Email iwamuromasaya@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Iwamuro
Organization Okayama University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7218
Homepage URL
Email iwamuromasaya@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Okayama University Hospital
Organization
Division
Category of Funding Organization Other
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
2017 Year 06 Month 12 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
2017 Year 07 Month 25 Day
Date of IRB
2017 Year 09 Month 08 Day
Anticipated trial start date
2017 Year 08 Month 15 Day
Last follow-up date
2022 Year 07 Month 31 Day
Date of closure to data entry
2022 Year 09 Month 30 Day
Date trial data considered complete
2022 Year 09 Month 30 Day
Date analysis concluded

Other
Other related information The main endpoints are i) the number of lymphocytes which can be evaluated by flow cytometry analysis, and ii) the rate of correct diagnosis of lymphoma by flow cytometry.

Management information
Registered date
2017 Year 06 Month 12 Day
Last modified on
2019 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031773

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.