UMIN-CTR Clinical Trial

Basic information
Public title	Single institutional database and retrospective analysis of clinico-pathological factor in lung cancer
Acronym	Single institutional database and retrospective analysis of clinico-pathological factor in lung cancer
Scientific Title	Single institutional database and retrospective analysis of clinico-pathological factor in lung cancer
Scientific Title:Acronym	Single institutional database and retrospective analysis of clinico-pathological factor in lung cancer
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this study, an investigation analyzes clinical practice information obtained from the medical treatment targeting at St. Marianna University School of Medicine Hospital, the primary lung cancer cases that it enforced an operation in respiratory surgery every day and builds databases such as the condition of a patient, diagnosis, treatment, convalescence. We recognize the actual situation of the primary lung cancer in our hospital for the cause with this database and am intended that we show a constant treatment guideline.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	I recognize the actual situation of the primary lung cancer and show a constant treatment guideline
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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Lung cancer
Key exclusion criteria	none
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Saji
Organization	St. Marianna University School of Medicine
Division name	Chest Surgery
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa,
TEL	044-977-8111
Email	saji-q@ya2.so-net.ne.jp

Public contact
Name of contact person	1st name Hisashi Middle name Last name Saji
Organization	St. Marianna University School of Medicine
Division name	Chest Surgery
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa,
TEL	044-977-8111
Homepage URL
Email	saji-q@ya2.so-net.ne.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	None
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	St. Marianna University School of Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki
Tel	08065624728
Email	hsaji@marianna-u.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	2022 Year 03 Month 11 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	Enrolling by invitation
Date of protocol fixation	2022 Year 03 Month 11 Day
Date of IRB	2022 Year 03 Month 11 Day
Anticipated trial start date	2022 Year 03 Month 11 Day
Last follow-up date	2025 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 03 Month 09 Day
Last modified on	2022 Year 03 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053751