UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004983 |
|---|---|
| Receipt number | 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 11:34:19 |
* 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
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
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
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005898
