UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011638 |
|---|---|
| Receipt number | R000013611 |
| Scientific Title | Multiinstitutional study of local recurrence after pulmonary metastasectomy |
| Date of disclosure of the study information | 2013/09/08 |
| Last modified on | 2021/09/09 18:22:33 |
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Basic information
Public title
Multiinstitutional study of local recurrence after pulmonary metastasectomy
Acronym
Local recurrence after pulmonary metastasectomy
Scientific Title
Multiinstitutional study of local recurrence after pulmonary metastasectomy
Scientific Title:Acronym
Local recurrence after pulmonary metastasectomy
Region
| Japan |
Condition
Condition
Metastatic lung tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To find the local recurrence after pulmonary metastasectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Three-year local recurrence rate
Key secondary outcomes
Three-year recurrence-free survival, recurrence pattern
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Metastatic lung tumor with wedge resection
Key exclusion criteria
Non-metastatic lung tumor with wedge resection, biopsy cases
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Kawamura |
Organization
Teikyo university school of medicine
Division name
Surgery
Zip code
173-0003
Address
2-11-1, Kaga, Itabasi-ku, Tokyo
TEL
03-3964-1231
mkawamur@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Shiono |
Organization
Yamagata Prefectural Central Hospital
Division name
Department of Thoracic Surgery
Zip code
990-2292
Address
1800, Ooazaaoyagi, Yamagata
TEL
023-685-2626
Homepage URL
sshiono@ypch.gr.jp
Sponsor or person
Institute
The Japanese Association for Metastatic Lung Tumor
Institute
Department
Personal name
Funding Source
Organization
The Japanese Association for Metastatic Lung Tumor
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
Yamagata Prefectural Central Hospital
Address
1800 Ooazaaoyagi, Yamagata
Tel
023-685-2626
sshiono@ypch.gr.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
| 2013 | Year | 09 | 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
177
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
| 2013 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrollment has been achieved.
Management information
Registered date
| 2013 | Year | 09 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013611
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/09/09 | １．断端再発研究プロトコール改訂09 08コピー.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/09/09 | 断端再発登録用紙20130416.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/09/09 | 断端再発研究.pdf |
