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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
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 | 2020/06/25 |
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 |
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Condition | |||||||||||||
Condition | lung cancer | ||||||||||||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |