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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002866
Receipt No. R000003495
Scientific Title Phase 0 study of three-dimensional endoscopic optical coherence tomography (u-VOIS)
Date of disclosure of the study information 2010/01/25
Last modified on 2014/05/16

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Basic information
Public title Phase 0 study of three-dimensional endoscopic optical coherence tomography (u-VOIS)
Acronym u-VOIS phase 0
Scientific Title Phase 0 study of three-dimensional endoscopic optical coherence tomography (u-VOIS)
Scientific Title:Acronym u-VOIS phase 0
Region
Japan

Condition
Condition Esophageal Cancer, Gastric Cancer, Colorectal Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Exploratory evaluation of new three-dimensional endoscopic optical coherence tomography.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Discrimination ability of mucosal membrane structure.
Discrimination ability of cancer tissue.
Key secondary outcomes

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 examinations of mucosal membrane using three-dimensional optical coherence tomography probe.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven esophageal cancer, gastric cancer and colon cancer.
2) Macroscopic morphological tumor type is as follows.
2)-1 Esophageal cancer:0-II or 0-III
2)-2 Gastric cancer: II or III
2)-3 Colon cancer: IIa, IIb, IIc, IIa+IIc, IIc+IIa
3)Endoscopic findings are as follows.
3)-1 Esophageal cancer: size of tumor is <= 3cm, depth of invasion is clinical T1a and located within the thoracic esophagus.
3)-2 Gastric cancer: size of tumor <=4cm with ulcer (-) and well differentiated adenocarcinoma, <=3cm with ulcer (+) and well differentiated adenocarcinoma, or <=2cm with poorly differentiated adenocartinoma. And depth of invasion is clinical M without pylorus or cardia invasion.
3)-3 Colon cancer: size of tumor <= 3cm, depth of invasion is clinical M or SM slight invasion.
4) no scar on the planned EMR area.
5) Clinical N0/M0
6) One-piece resection is possible with EMR
7) Aged 20 to 80 years old.
8) PS (ECOG) of 0 or1.
9) without synchronous or metachronous cancer
10) No prior treatment of surgery, chemotherapy or radiation for cancer.
11) Sufficient organ function.
12) Written informed consent.
Key exclusion criteria 1) Impossible to discontinue anticoagulant or antiplatelet medication.
2) Women during pregnancy or breast-feeding.
3) Psychosis.
4) Systemic steroids medication.
5) Active bacterial or fungal infection.
6) History of myocardial infarction or unstable angina pectoris within three months.
7) Uncontrollable hypertension.
8) Uncontrollable diabetes mellitus or administration of insulin.
9) History of allergy to latex.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kaneko
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
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 Department of Gastrointestinal Oncology
Zip code
Address
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 Japan

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
2010 Year 01 Month 25 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
2009 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 09 Day
Last modified on
2014 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003495

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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