UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030099 |
|---|---|
| Receipt number | R000034355 |
| Scientific Title | Prospective cohort study to examine exacerbation frequency and risk factors for joint symptoms related to postoperative endocrine treatment in breast cancer patients |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2017/11/24 10:07:10 |
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Basic information
Public title
Prospective cohort study to examine exacerbation frequency and risk factors for joint symptoms related to postoperative endocrine treatment in breast cancer patients
Acronym
Prospective cohort study on joint symptoms by postoperative endocrine treatment
Scientific Title
Prospective cohort study to examine exacerbation frequency and risk factors for joint symptoms related to postoperative endocrine treatment in breast cancer patients
Scientific Title:Acronym
Prospective cohort study on joint symptoms by postoperative endocrine treatment
Region
| Japan |
Condition
Condition
hormone-receptor-positive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of incidence and exacerbation rate and risk factors for joint symptoms related to endocrine treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exacerbation rate of joint symptoms for 1 year after starting endocrine treatment
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
Female
Key inclusion criteria
1.Estrogen receptor positive primary breast cancer patients
2.Patients who start postoperative endocrine treatment
Key exclusion criteria
Patients judged inappropriate by doctors
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naruto Taira |
Organization
Okayama University Hospital
Division name
Breast and Endocrine Surgery
Zip code
Address
2-5-1 Shikata-cho, Kitaku, Okayama city, Okayama
TEL
086-235-7265
ntaira@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naruto Taira |
Organization
Okayama University Hospital
Division name
Breast and Endocrine Surgery
Zip code
Address
2-5-1 Shikata-cho, Kitaku, Okayama city, Okayama
TEL
086-235-7265
Homepage URL
ntaira@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Breast and Endocrine Surgery,
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 01 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of incidence and exacerbation for joint symptoms related to endocrine treatment using a questionnaire
Management information
Registered date
| 2017 | Year | 11 | Month | 24 | Day |
Last modified on
| 2017 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034355
| 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 |
