UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042692
Receipt number R000048721
Scientific Title Study of recurrent laryngeal papillomatosis by Single-cell transcriptomic analysis
Date of disclosure of the study information 2020/12/10
Last modified on 2023/06/11 21:03:29

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Basic information

Public title

Study of recurrent laryngeal papillomatosis by Single-cell transcriptomic analysis

Acronym

Single-cell transcriptomic analysis for recurrent laryngeal papillomatosis

Scientific Title

Study of recurrent laryngeal papillomatosis by Single-cell transcriptomic analysis

Scientific Title:Acronym

Single-cell transcriptomic analysis for recurrent laryngeal papillomatosis

Region

Japan


Condition

Condition

Recurrent respiratory papillomatosis, recurrent laryngeal papillomatosis

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The purpose of this study is to identify key cells/molecules related to progression of recurrent respiratory papillomatosis by single-cell transcriptomic analysis for the development of therapies.

Basic objectives2

Others

Basic objectives -Others

Pathological and molecular biological mechanisms

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Key cells and molecules related to progression of papillomatosis, tumor recurrence

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Diagnosed as recurrent respiratory papillomatosis or recurrent laryngeal papillomatosis

Provide written informed consent

Key exclusion criteria

Be concluded not eligible to enter the study by a principle investigator or sub-investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Rumi
Middle name Ueha
Last name Ueha

Organization

The University of Tokyo

Division name

Swallowing Center

Zip code

113-8655

Address

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

TEL

03-3815-5411

Email

UEHAR-OTO@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Rumi
Middle name
Last name Ueha

Organization

The University of Tokyo

Division name

Swallowing Center

Zip code

113-8655

Address

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

TEL

03-3815-5411

Homepage URL


Email

UEHAR-OTO@h.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

University Research Grants

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the University of Tokyo

Address

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

Tel

03-5841-3600

Email

hy-ohrs@m.u-tokyo.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

20011

Org. issuing International ID_1

Tokyo University of Science

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 10 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 07 Month 27 Day

Date of IRB

2020 Year 07 Month 27 Day

Anticipated trial start date

2020 Year 12 Month 10 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The purpose of this study is to identify key cells/molecules (therapeutic targets) related to RRP progression for the development of therapies.


Management information

Registered date

2020 Year 12 Month 08 Day

Last modified on

2023 Year 06 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048721


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name