UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016557 |
|---|---|
| Receipt number | R000019213 |
| Scientific Title | Feasibilisy and safety study of probe based confocal laser endomicroscopy for gastrointestinal cancer |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2022/08/23 15:13:22 |
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Basic information
Public title
Feasibilisy and safety study of probe based confocal laser endomicroscopy for gastrointestinal cancer
Acronym
CLEAR pilot study
Scientific Title
Feasibilisy and safety study of probe based confocal laser endomicroscopy for gastrointestinal cancer
Scientific Title:Acronym
CLEAR pilot study
Region
| Japan |
Condition
Condition
Early gastric cancer and colorectal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. Assess efficacy of probe based confocal laser endomicroscopy (pCLE) for gastrointestinal neoplasm by comparing microendoscopic and histological findings.
2. Evaluate safety of fluorescene for pCLE in Japanese patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Achieve effective histological prediction such as malignancy, histological type and lateral tumor extention of gastrointestinal neoplasm by pCLE
Key secondary outcomes
Confirm safety of fluorescene for pCLE in Japanese patients
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
| Medicine | Device,equipment |
Interventions/Control_1
1. pCLE
2. Intravenous fluorescene administration on pCLE
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, A patient with eary gastric cancer or colorectal neoplasm who is going to undergo endoscopic treatment or surgery.
2, Obtained written informed concent.
3, Fulfilled all of the laboratory data mentioned below within 60 days before enrollment.
WBC =>3,000/mm3
Hb =>8.0g/dl
Plt =>100,000
T.BIl <=2.0mg/dl
AST(GOT) <=100 IU/l
ALT (GPT) <=100 IU/l
Cre <=1.5 mg/dl
Key exclusion criteria
Those who have comorbidities or clinical issue mentioned below are excluded;
1. Severe chronic anemia or thrombocytopenia which is not tolerable for endodscopic treatment or surgery
2. Allergy for fluorescene
3. Phaeochromocytoma, malignany hypertention or severe heart failure within 3 months
4. Uncontrolled diabetes mellitus
5. Severe pulmonary fibrosis or interstitial pneumonia
6. Uncontrolled infection
7. Pregnancy or lactation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Saito |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3254-2511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichiro Abe |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3254-2511
Homepage URL
seabe@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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中央病院
・国立がん研究センター東病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 16 | 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
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 29 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019213
