UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030615
Receipt number R000034964
Scientific Title Cohort study of elderly with head and neck cancer
Date of disclosure of the study information 2017/12/28
Last modified on 2020/12/30 10:44:52

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Basic information

Public title

Cohort study of elderly with head and neck cancer

Acronym

elderly with head and neck cancer

Scientific Title

Cohort study of elderly with head and neck cancer

Scientific Title:Acronym

elderly with head and neck cancer

Region

Japan


Condition

Condition

Head and neck cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine treatment status and prognosis of elderly with head and neck cancers

Basic objectives2

Others

Basic objectives -Others

To examine treatment status and prognosis of elderly with head and neck cancers

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Completion rate of treatment
Overall survival rate

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

75 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Aquamous cell carcinoma of oral cavity, pharynx, larynx.

Key exclusion criteria

None

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Shigeru
Middle name
Last name Hirano

Organization

Kyoto prefectural university of medicine

Division name

Department of Otolaryngology Head and Neck Surgery

Zip code

6028566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, JAPAN

TEL

075-251-5603

Email

hirano@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Akihito
Middle name
Last name Arai

Organization

Kyoto prefectural university of medicine

Division name

Department of Otolaryngology Head and Neck Surgery

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, JAPAN

TEL

0752515603

Homepage URL

http://www.f.kpu-m.ac.jp/k/ent/

Email

hirano@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto prefectural university of medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto prefectural university of medicine

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

IRB Kyoto Prefectural University of Medicine

Address

Kajii-cho, Kamigyo-ku, Kyoto 602-8566

Tel

0752515111

Email

rinri@koto.kpu-m.ac.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

2017 Year 12 Month 28 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

2017 Year 10 Month 12 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study to pursue elderly with head and neck cancers


Management information

Registered date

2017 Year 12 Month 28 Day

Last modified on

2020 Year 12 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034964


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name