UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013293 |
|---|---|
| Receipt number | R000015498 |
| Scientific Title | Evaluation of efficacy of postoperative follow-up after resection for lung cancer |
| Date of disclosure of the study information | 2014/02/27 |
| Last modified on | 2016/02/28 09:37:37 |
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Basic information
Public title
Evaluation of efficacy of postoperative follow-up after resection for lung cancer
Acronym
postoperative follow-up for lung cancer
Scientific Title
Evaluation of efficacy of postoperative follow-up after resection for lung cancer
Scientific Title:Acronym
postoperative follow-up for lung cancer
Region
| Japan |
Condition
Condition
Patients who underwent resection for lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of postoperative follow-up path prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Detection rates of recuurence at the three-years after resection (symptomatice or asymptomatic)
Key secondary outcomes
Completion rate of postopertaive follow-up.
Five-year survival rate.
Treatment for the recurrence.
Recurrence site.
Detection rate of metachronous cancer
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
1.Completely resected comfirmed non-small cell lung cancer.
2.Obtained informed concent
Key exclusion criteria
1.Active other organ cancer.
2.Judged an improper case by a doctor
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shikgei Sawada |
Organization
Shikoku Cancer Center
Division name
Department of Thoracic Surgery
Zip code
Address
160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture
TEL
089-999-1111
ssawada@shikoku-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Sawada |
Organization
Shikoku Cancer Center
Division name
Department of Thoracic Surgery
Zip code
Address
160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture
TEL
089-999-1111
Homepage URL
http://www.shikoku-cc.go.jp/hospital/
ssawada@shikoku-cc.go.jp
Sponsor or person
Institute
Shikoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
N/A
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
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
| 2014 | Year | 02 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | 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
N/A
Management information
Registered date
| 2014 | Year | 02 | Month | 27 | Day |
Last modified on
| 2016 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015498
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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