UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007760
Receipt number R000009139
Scientific Title PHARYNGEAL CANCER SURVEILLANCE USING NARROW BAND IMAGING DURING UPPER GASTROINTESTINAL ENDOSCOPY
Date of disclosure of the study information 2012/04/14
Last modified on 2012/04/14 16:47:48

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Basic information

Public title

PHARYNGEAL CANCER SURVEILLANCE USING NARROW BAND IMAGING DURING UPPER GASTROINTESTINAL ENDOSCOPY

Acronym

PHARYNGEAL CANCER SURVEILLANCE USING NARROW BAND IMAGING DURING UPPER GASTROINTESTINAL ENDOSCOPY

Scientific Title

PHARYNGEAL CANCER SURVEILLANCE USING NARROW BAND IMAGING DURING UPPER GASTROINTESTINAL ENDOSCOPY

Scientific Title:Acronym

PHARYNGEAL CANCER SURVEILLANCE USING NARROW BAND IMAGING DURING UPPER GASTROINTESTINAL ENDOSCOPY

Region

Japan


Condition

Condition

Pharyngeal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to estimate the prevalence of pharyngeal cancer in asymptomatic high-risk group

Basic objectives2

Others

Basic objectives -Others

to evaluate the feasibility of pharyngeal observation as a part of conventional gastrointestinal (GI) endoscopy.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the detection rate of pharyngeal cancer

Key secondary outcomes

the feasibility of pharyngeal observation


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

pharyngeal observation during conventional upper GI endoscopy

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

male,
over 50 years,
consumption of alcohol and smoking,
including prior history of esophageal SCC,
written informed consent

Key exclusion criteria

with advanced pharyngeal cancer,
mental disorder or psychiatric symptom

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Saito Mayuko

Organization

Sapporo Medical University

Division name

First Department of Internal Medicine

Zip code


Address

S-1, W-16, Chuo-ku, Sapporo, Hokkaido

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Sapporo Medical University

Division name

First Department of Internal Medicine

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

First Department of Internal Medicine,
Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

First Department of Internal Medicine,
Sapporo Medical University

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

Muroran City General Hospital,
First Department of Internal Medicine,Sapporo Medical University


Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2008 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2008 Year 02 Month 01 Day

Last follow-up date

2009 Year 10 Month 01 Day

Date of closure to data entry

2009 Year 10 Month 01 Day

Date trial data considered complete

2010 Year 02 Month 01 Day

Date analysis concluded

2010 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 04 Month 14 Day

Last modified on

2012 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009139


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name