UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040329
Receipt number R000045992
Scientific Title Research on lung cancer at Saiseikai Nakatsu Hospital
Date of disclosure of the study information 2020/05/09
Last modified on 2020/09/06 10:33:45

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Basic information

Public title

Research on lung cancer at Saiseikai Nakatsu Hospital

Acronym

Research on lung cancer at Saiseikai Nakatsu Hospital

Scientific Title

Research on lung cancer at Saiseikai Nakatsu Hospital

Scientific Title:Acronym

Reserch on lung cancer at Saiseikai Nakatsu Hospital

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the distribution of patients with lung cancer at Saiseikai Nakatsu Hospital

Basic objectives2

Others

Basic objectives -Others

To clarify the number of patients with small cell, adenocarcinoma, and squamous cell carcinoma

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The number of patients with small cell, adenocarcinoma, and squamous cell carcinoma in lung cancer

Key secondary outcomes

Treatment of small cell lung cancer and non-small cell lung cancer
OS and PFS of small cell lung cancer and non-small cell lung cancer
Direct medical expenses about lung cancer
Risk factors of poor treatment response
Risk factors of poor OS in patients with lung adenocarcinoma


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 hospitalization history of lung cancer at Saiseikai Nakatsu Hospital.

Key exclusion criteria

Patients with another active cancer disease.
Patients treated with lung cancer in another hospital.
Patients without data of OS.
Patients who reject the participation in this study,

Target sample size

1200


Research contact person

Name of lead principal investigator

1st name Tetsuya
Middle name
Last name Ueda

Organization

Osaka Saiseikai Nakatsu Hospital

Division name

Respiratory Medicine

Zip code

530-0012

Address

2-10-39, Shibata, Kita-ku, Osaka

TEL

06-6372-0333

Email

t-ueda@nakatsu.saiseikai.or.jp


Public contact

Name of contact person

1st name Tetsuya
Middle name
Last name Ueda

Organization

Osaka Saiseikai Nakatsu Hospital

Division name

Respiratory Medicine

Zip code

530-0012

Address

2-10-39, Shibata, Kita-ku, Osaka

TEL

06-6372-0333

Homepage URL


Email

t-ueda@nakatsu.saiseikai.or.jp


Sponsor or person

Institute

Social Welfare Organization

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Osaka Saiseikai Nakatsu Hospital

Address

2-10-39, Shibata, Kita-ku, Osaka

Tel

06-6372-0333

Email

d_torii@nakatsu.saiseikai.or.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2019-73

Org. issuing International ID_1

Ethics Review Committee

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 05 Month 09 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

2014 Year 11 Month 30 Day

Date of IRB

2020 Year 02 Month 12 Day

Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2020 Year 05 Month 08 Day

Last modified on

2020 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045992


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name