UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041785
Receipt number R000047691
Scientific Title Treatment of laryngeal cancer in Japan
Date of disclosure of the study information 2020/09/15
Last modified on 2021/09/15 11:35:09

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Basic information

Public title

Variation of treatment decision-making for laryngeal cancer in Japan a retrospective observational study using a nationalwide database

Acronym

Treatment of laryngeal cancer in Japan

Scientific Title

Treatment of laryngeal cancer in Japan

Scientific Title:Acronym

Treatment of laryngeal cancer in Japan

Region

Japan


Condition

Condition

Laryngeal cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the variation of treatment decision-making for laryngeal cancer in Japan

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Type of initial treatment

Key secondary outcomes

Regimens of radiotherapy


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

200 years-old >

Gender

Male and Female

Key inclusion criteria

Patients were identified using Diagnosis Procedure Combination (DPC) data, and target ICD-10 (C320, C321, C322, C329)

Key exclusion criteria

T4, N3, or M1 cases, as well as patients with unclear T stage, were excluded. Patients who had surgeries with Japanese procedure code C112 (tracheostomy), K394-2 (laryngectomy), K395 (pharyngolaryngectomy), K403-2-4 (laryngotracheal separation), and K403-2-3 (total laryngectomy for aspiration) before the index date, were also excluded.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Fujiwara

Organization

Kurashiki Central Hospital

Division name

Otolaryngology

Zip code

7108602

Address

Miwa 1-1-1, Kurashiki city, Okayama, Japan

TEL

086-422-0210

Email

t.fujiwarabi@gmail.com


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Fujiwara

Organization

Kurashiki Central Hospital

Division name

Otolaryngology

Zip code

7108602

Address

Miwa 1-1-1, Kurashiki city, Okayama, Japan

TEL

086-422-0210

Homepage URL


Email

t.fujiwarabi@gmail.com


Sponsor or person

Institute

Kurashiki Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Kurashiki Central Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kurashiki Central Hospital

Address

Miwa 1-1-1, Kurashiki city, Okayama, Japan

Tel

086-422-0210

Email

tf14817@kchnet.or.jp


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

2020 Year 09 Month 15 Day


Related information

URL releasing protocol

Unpublished

Publication of results

Unpublished


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/ace/3/3/3_No.21-12/_article/-char/ja

Number of participants that the trial has enrolled

363

Results

Larynx-preserving treatment was used in most T1 and T2 cases (96.9%), and 40% of the patients with T3 cancer underwent total laryngectomy (adjusted odds ratio 26.7 [95% CI, 9.29-91.6]).

Results date posted

2021 Year 07 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 07 Month 01 Day

Baseline Characteristics

Mean age(year) 71.8
Gender(male/female) 333/30

Participant flow

Extracted from Database

Adverse events

Not evaluated

Outcome measures

Treatment pattern

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 09 Month 30 Day

Date of IRB

2019 Year 10 Month 31 Day

Anticipated trial start date

2019 Year 10 Month 31 Day

Last follow-up date

2019 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a medical database study using RWD database from HCEI. The dataset for this study was cut from the database in September 2019.


Management information

Registered date

2020 Year 09 Month 14 Day

Last modified on

2021 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047691


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name