UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of clinical database for re-biopsy patients with primary lung cancer
Acronym	Clinical database of re-biopsy lung cancer patients
Scientific Title	Establishment of clinical database for re-biopsy patients with primary lung cancer
Scientific Title:Acronym	Clinical database of re-biopsy lung cancer patients
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Medicine in general Pneumology Surgery in general Chest surgery Obsterics and gynecology Dermatology Oto-rhino-laryngology Orthopedics Urology Radiology Neurosurgery Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the clinical features of re-biopsy cases by collecting the clinical, pathological and gene alteration data from the patients with lung cacenr.
Basic objectives2	Others
Basic objectives -Others	To develop the optimal strategies for re-biopsy and selection of the treatment plan for lung cancer (precision medicine).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pathological diagnosis, results of gene alteration analysis, selected treatment plan, and prognosis
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Lung cancer patients who underwent re-biopsy.
Key exclusion criteria	The patients who were judged as inadequate for this database by registered physicians of this study.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Yoshino
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Zip code	2608670
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Email	koge@office.chiba-u.jp

Public contact
Name of contact person	1st name Takahiro Middle name Last name Nakajima
Organization	Chiba University Graduate School of Medicine
Division name	Department of General Thoracic Surgery
Zip code	2608670
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Homepage URL
Email	takahiro_nakajima@med.miyazaki-u.ac.jp

Sponsor
Institute	Department of General Thoracic Surgery, Chiba University Graduate School of Medicine
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	Chiba University Graduate School of Medicine
Address	1-8-1, Inohana, Chuo-ku, Chiba
Tel	043-222-7171
Email	inohana-rinri@chiba-u.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 07 Month 01 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	75
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	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 22 Day
Date of IRB	2016 Year 12 Month 28 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	(1) Patients' background (2) Clinical course (3) Phisiological exam data (4) Results of blood exams (5) Results of microbiology (6) Results of radiological exams (7) Results of pathology (8) Details of surgery (9) Details of re-biopsy (10) Results of gene alteration testings (11) Results of immunohistochemistry (12) Selected treatment (13) Prognosis

Management information
Registered date	2017 Year 06 Month 22 Day
Last modified on	2019 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031930

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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