UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027865 |
|---|---|
| Receipt number | 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 | 2020/06/25 11:12:46 |
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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 | Obstetrics 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
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
takahiro_nakajima@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of General Thoracic Surgery, Chiba University Graduate School of Medicine
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
Chiba University Graduate School of Medicine
Address
1-8-1, Inohana, Chuo-ku, Chiba
Tel
043-222-7171
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
Main results already published
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
| 2020 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.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 |
