UMIN-CTR Clinical Trial

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
Institute	Social Welfare Organization
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045992