UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018602 |
|---|---|
| Receipt number | R000021528 |
| Scientific Title | Isolated tumor cell in lung cancer operation, multi center, prospective, observational study |
| Date of disclosure of the study information | 2015/08/08 |
| Last modified on | 2024/02/13 09:39:36 |
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Basic information
Public title
Isolated tumor cell in lung cancer operation, multi center, prospective, observational study
Acronym
Isolated tumor cell in lung cancer operation, ILO1501
Scientific Title
Isolated tumor cell in lung cancer operation, multi center, prospective, observational study
Scientific Title:Acronym
Isolated tumor cell in lung cancer operation, ILO1501
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to know the prognostic factor aroun lung cancer operation using isolated tumor cell.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
detection of isolated tumor cell using Screen Cell method
Key secondary outcomes
relation of isolated tumor cell and pathological factor
relation of isolated tumor cell and operation time
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Preoperative diagnosis as primary non small cell lung cancer
2.clinical stage, T1b-T2, N0M0
3.lobectomy, bi-lobectomy or pneumonectomy
4.consolidation/GGO ratio > 50%
5.ECOG PS0,1
6. chemotherapy naive
7. having operabirity
Key exclusion criteria
1. other active malingant tumor
2. HBV, HCV, HIV
3. fever up over 38
4. having steroid therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyoshi Sawabata |
Organization
Hoshigaoca Medical Center
Division name
thoracic surgery
Zip code
Address
4-8-1 Hoshigaoka, Maikata city, Osaka, Japan
TEL
06-6879-2595
nsawabata@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Matsutani |
Organization
Teikyo University School of Medicine
Division name
Surgery
Zip code
Address
2-11-1 Kaga, Itabashi-ku Tokyo, Japan
TEL
03-3964-1231
Homepage URL
matsutan@med.teikyo-u.ac.jp
Sponsor or person
Institute
Hoshigaoca Medical Center
Institute
Department
Personal name
Funding Source
Organization
B 25293301
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
星ヶ丘医療センター（大阪府）
山形県立中央病院（山形県）
九州がんセンター（福岡県）
帝京大学（東京都）
浜松医大（静岡県）
順天堂大学（東京都）
東京医大（東京都）
済生会横浜市南部病院（神奈川県）
大阪大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 08 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
isolated tumor cell using Screen Cell method
pathological factor
operative factor
Management information
Registered date
| 2015 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021528
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
