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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027865
Receipt No. R000031930
Scientific Title Establishment of clinical database for re-biopsy patients with primary lung cancer
Date of disclosure of the study information 2017/07/01
Last modified on 2017/12/26

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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
Middle name
Last name Ichiro Yoshino
Organization Chiba University Graduate School of Medicine
Division name Department of General Thoracic Surgery
Zip code
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
Middle name
Last name Takahiro Nakajima
Organization Chiba University Graduate School of Medicine
Division name Department of General Thoracic Surgery
Zip code
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
Address
Tel
Email

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
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
2016 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
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
2017 Year 12 Month 26 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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