UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011849
Receipt number R000013851
Scientific Title Efficacy of BLI for superficial pharyngeal or esophageal squamous cell carcinoma
Date of disclosure of the study information 2013/09/24
Last modified on 2016/09/26 18:38:55

* 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

Efficacy of BLI for superficial pharyngeal or esophageal squamous cell carcinoma

Acronym

Comaparative trial of BLI versus white-light endoscopy

Scientific Title

Efficacy of BLI for superficial pharyngeal or esophageal squamous cell carcinoma

Scientific Title:Acronym

Comaparative trial of BLI versus white-light endoscopy

Region

Japan


Condition

Condition

superficial pharyngeal or esophageal squamous cell carcinoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of BLI system for detection of simultaneous pharyngeal cancer or metachronous esophageal cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

detection rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

BLI endocsopic examination

Interventions/Control_2

white-light examination

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1)SCC
2)age:20-90 years old
3)obtained written informed consent
4)PS: 0-2
5)No iodine allergy
6)No severe underlying disease

Key exclusion criteria

1)History of radiation in the field of neck and mediastinum
2)History of esophagectomy
3)Infectious condition
4)poor controlled HT, IHD, or Arrhythmia
5)psychological disorder
6)Discontinuation of anticoagulant therapy was impossible

Target sample size

160


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuru Kaise

Organization

Toranomon Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-2-2 toranomon Minato-ku Tokyo

TEL

03-3588-1111

Email

kaise@toranomon.gr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiro Iizuka

Organization

Toranomon Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-2-2 toranomon Minato-ku Tokyo

TEL

03-3588-1111

Homepage URL


Email

t-iizuka@toranomon.gr.jp


Sponsor or person

Institute

Department of Gastroenterology, Toranomon Hospital

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

2013 Year 09 Month 24 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

Enrolling by invitation

Date of protocol fixation

2013 Year 03 Month 29 Day

Date of IRB


Anticipated trial start date

2013 Year 04 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

2013 Year 09 Month 24 Day

Last modified on

2016 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013851


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name