UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003655
Receipt number R000004424
Scientific Title Intraoperative identification of hepato-biliary-pancreatic cancers using fluorescence probes with peptidase activity
Date of disclosure of the study information 2010/06/01
Last modified on 2010/11/24 10:47:17

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Basic information

Public title

Intraoperative identification of hepato-biliary-pancreatic cancers using fluorescence probes with peptidase activity

Acronym

Intraoperative identification of hepato-biliary-pancreatic cancers using fluorescence probes with peptidase activity

Scientific Title

Intraoperative identification of hepato-biliary-pancreatic cancers using fluorescence probes with peptidase activity

Scientific Title:Acronym

Intraoperative identification of hepato-biliary-pancreatic cancers using fluorescence probes with peptidase activity

Region

Japan


Condition

Condition

Hepato-biliary-pancreatic cancers

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To identify hepato-biliary-pancreatic cancers using fluorescence probes during surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sensitivity and specificity of fluorescence probes for identifying hepato-biliary-pancreatic cancers

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

Medicine Device,equipment

Interventions/Control_1

Use of fluorescence probes

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are to undergo resection for hepato-biliary-pancreatic cancers

Key exclusion criteria

None

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiro KOKUDO

Organization

Graduate School of Medicine, University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code


Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Takeaki ISHIZAWA

Organization

Graduate School of Medicine, University of Tokyo

Division name

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Zip code


Address


TEL


Homepage URL


Email

tish-tky@umin.ac.jp


Sponsor or person

Institute

Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2010 Year 06 Month 01 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

Open public recruiting

Date of protocol fixation

2010 Year 05 Month 13 Day

Date of IRB


Anticipated trial start date

2010 Year 05 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

2010 Year 05 Month 24 Day

Last modified on

2010 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004424


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name