UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002866 |
|---|---|
| Receipt number | 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 09:40:17 |
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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
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
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
Japan
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003495
