UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016999 |
|---|---|
| Receipt number | R000018189 |
| Scientific Title | Prospective cohort study of lung oligometastasis of breast cancer |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2020/10/03 09:35:40 |
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Basic information
Public title
Prospective cohort study of lung oligometastasis of breast cancer
Acronym
SBP-06
Scientific Title
Prospective cohort study of lung oligometastasis of breast cancer
Scientific Title:Acronym
SBP-06
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospective analysis of diagnosis, treatment strategy and prognosis of lung oligometastasis of breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of lung oligometastasis of breast cancer
Key secondary outcomes
Efficacy and safety of surgery for lung oligometastasis of breast 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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)First metastasis after curable breast cancer surgery
(2)under 3 lung metastasesdiagnosed by CT, PET/CT or biposy.
(3)only lung metastasis
(4)ER, PgR and HER2 expression were diagnosed by primary breast cancer tumor
Key exclusion criteria
none
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tadahiko |
| Middle name | |
| Last name | Shien |
Organization
Okayama University Hospital
Division name
Breast and Endocrine surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81862357265
tshien@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadahiko |
| Middle name | |
| Last name | Shien |
Organization
Setouchi Breast Project
Division name
Crinical trial committiee
Zip code
700-8558
Address
2-5-1 Shikata-cho. Kita-ku, Okayama
TEL
086-235-7265
Homepage URL
tshien@md.okayama-u.ac.jp
Sponsor or person
Institute
Setouchi Breast Project
Institute
Department
Personal name
Funding Source
Organization
Setouchi Breast Project
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital, Ethics Committee
Address
1-5-2 Shikata-cho, Kita-ku
Tel
086-235-7265
tshien@md.okayama-u.ac.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
| 2015 | Year | 03 | Month | 31 | 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
| 2014 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Diagnosis, treatment strategy and prognosis of lung oligometastasis of breast cancer
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2020 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018189
