UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042303
Receipt number R000048200
Scientific Title A prospective observational study evaluating the efficacy of endocytoscopy for the diagnosis of pharyngeal intraepithelial neoplasias.
Date of disclosure of the study information 2020/10/31
Last modified on 2020/10/31 07:56:17

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Basic information

Public title

A prospective observational study evaluating the efficacy of endocytoscopy for the diagnosis of pharyngeal intraepithelial neoplasias.

Acronym

Efficacy of endocytoscopy for the diagnosis of pharyngeal intraepithelial neoplasias

Scientific Title

A prospective observational study evaluating the efficacy of endocytoscopy for the diagnosis of pharyngeal intraepithelial neoplasias.

Scientific Title:Acronym

Efficacy of endocytoscopy for the diagnosis of pharyngeal intraepithelial neoplasias

Region

Japan


Condition

Condition

Pharyngeal intraepithelial neoplasias

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the endocytoscopy for the diagnosis of pharyngeal intraepithelial neoplasias

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic rate (accuracy/sensitivity/specificity)

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with pharyngeal intraepithelial neoplasias

Key exclusion criteria

Patients in disagreement with informed consent
Others

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kimoto
Middle name
Last name Yoshiaki

Organization

NTT Medical Center Tokyo

Division name

Department of Gastrointestinal endoscopy

Zip code

141-8625

Address

5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan

TEL

+81-3-3448-6111

Email

kimoto.yoshiaki@gmali.com


Public contact

Name of contact person

1st name Kimoto
Middle name
Last name Yoshiaki

Organization

NTT Medical Center Tokyo

Division name

Department of Gastrointestinal endoscopy

Zip code

141-8625

Address

5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan

TEL

+81-3-3448-6111

Homepage URL


Email

kimoto.yoshiaki@gmali.com


Sponsor or person

Institute

NTT Medical Center Tokyo

Institute

Department

Personal name



Funding Source

Organization

NTT Medical Center Tokyo

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Yamaga Chuo Hospital, Kumamoto

Name of secondary funder(s)



IRB Contact (For public release)

Organization

NTT Medical Center Tokyo

Address

5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan

Tel

+81-3-3448-6111

Email

kimoto.yoshiaki@gmali.com


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

NTT東日本関東病院、山鹿中央病院


Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 31 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

2020 Year 10 Month 31 Day

Date of IRB

2020 Year 10 Month 09 Day

Anticipated trial start date

2020 Year 10 Month 31 Day

Last follow-up date

2025 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2020 Year 10 Month 31 Day

Last modified on

2020 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048200


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name