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

* 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

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

Email

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


Email

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


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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2015/07/30 150730UMIN固定データ.xlsx