UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047149 |
|---|---|
| Receipt number | R000053784 |
| Scientific Title | Prognosis and treatment of asymptomatic versus symptomatic metastatic breast cancer: A multicenter retrospective study |
| Date of disclosure of the study information | 2022/03/11 |
| Last modified on | 2022/09/14 14:02:08 |
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Basic information
Public title
Prognosis and treatment of asymptomatic versus symptomatic metastatic breast cancer: A multicenter retrospective study
Acronym
Prognosis and treatment of asymptomatic versus symptomatic metastatic breast cancer: A multicenter retrospective study
Scientific Title
Prognosis and treatment of asymptomatic versus symptomatic metastatic breast cancer: A multicenter retrospective study
Scientific Title:Acronym
Prognosis and treatment of asymptomatic versus symptomatic metastatic breast cancer: A multicenter retrospective study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to determine whether differences in clinicopathological features, subtypes, prognosis, and treatment of luminal BC exist between asymptomatic and symptomatic MBCs.
Basic objectives2
Others
Basic objectives -Others
This study aimed to determine whether differences in clinicopathological features, subtypes, prognosis, and treatment of luminal BC exist between asymptomatic and symptomatic MBCs.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival, post-recurrence survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
metastatic breast cancer
Key exclusion criteria
unknown for treatment
unknown for symptoms at the diagnosis of metastatic breast cancer
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | susumu |
| Middle name | |
| Last name | eguchi |
Organization
Nagasaki university hospital
Division name
Surgery
Zip code
8528501
Address
1-7-1, Sakamoto-machi
TEL
0958197316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuba |
Organization
Nagasaki university hospital
Division name
Surgery
Zip code
8528501
Address
1-7-1, Sakamoto-machi
TEL
0958197316
Homepage URL
skuba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki university hospital
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1, Sakamoto-machi
Tel
0958197316
gaibushikin@ml.nagasaki-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
| 2022 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35982150/
Number of participants that the trial has enrolled
204
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
| 2021 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not otherwise specified
Management information
Registered date
| 2022 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053784
