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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004983
Receipt No. R000005898
Scientific Title Phase 0 study of new spectrum imaging endoscopy
Date of disclosure of the study information 2011/02/01
Last modified on 2014/06/13

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Basic information
Public title Phase 0 study of new spectrum imaging endoscopy
Acronym Sie Phase 0
Scientific Title Phase 0 study of new spectrum imaging endoscopy
Scientific Title:Acronym Sie Phase 0
Region
Japan

Condition
Condition Suspected or early oropharynx, hypopharynx, esophagus, stomach or colon cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Exploratory evaluation of new spectrum imaging endoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of new spectrum image
Key secondary outcomes Adverse events
Time needed for endoscopy

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Endoscopic diagnosis of new spectrum imaging 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) aged 20 or over
2) PS (ECOG) of 0 or 1
3) Written informed consent
4) Meet following A) or B) criteria
A) Endoscopic examination for euplastic lesion of or pharynx, hypo pharynx, esophagus, stomach or colon is scheduled
B) Meet all following criteria
4B-i) EMR or ESD for early stage cancer of or pharynx, hypo pharynx, esophagus, stomach or colon is scheduled
4B-ii) no prior surgery, chemotherapy or radiation for cancer in the target organ
4B-iii)sufficient organ function
Key exclusion criteria 1) impossible to discontinue anticoagulant or antiplatelet medication.
2) women during pregnancy or breast-feeding.
3) psychosis.
4) ileus, obstruction or perforation of the digestive tract
5) active bacterial or fungal infection.
6) history of myocardial infarction or unstable angina pectoris within three months.
7) uncontrollable hypertension.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kaneko
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
Homepage URL
Email

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization FUJIFILM Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Jaqpan

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 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24915532
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
2011 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 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
2011 Year 01 Month 31 Day
Last modified on
2014 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005898

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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