UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023112 |
|---|---|
| Receipt number | R000026421 |
| Scientific Title | Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients |
| Date of disclosure of the study information | 2016/07/12 |
| Last modified on | 2018/07/13 12:37:07 |
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Basic information
Public title
Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients
Acronym
Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients
Scientific Title
Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients
Scientific Title:Acronym
Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Reveal the side effects and QOL after the start of endocrine treatment for pre-menopausal breast cancer patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
side effect of the incidence of post-dose after 3 months and QOL
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. premenopausal women
2. Breast cancer patients with hormone receptor-positive
3. Patients scheduled to administer the LH-RH agonist
4. Preoperative or postoperative hormone receptor-positive patient , hormone receptor-positive patients with no prior treatment as metastatic or recurrent treatment
Key exclusion criteria
1. Patients undergoing total hysterectomy surgery of the uterus
2. Patients registration to this study is deemed difficult due to mental disorders clinically relevant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Miyamoto |
Organization
Hamamatsu Medical Center
Division name
Division of Pharmacy
Zip code
Address
Tomidzuka-cho 328 Nakaku Hamamatsu Shizuoka
TEL
053-453-7111
ymiyamo@hmedc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Miyamoto |
Organization
Hamamatsu Medical Center
Division name
Division of Pharmacy
Zip code
Address
Tomidzuka-cho 328 Nakaku Hamamatsu Shizuoka
TEL
053-453-7111
Homepage URL
ymiyamo@hmedc.or.jp
Sponsor or person
Institute
Hamamatsu Medical Center, Division of Pharmacy
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Medical Center, Division of Pharmacy
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
浜松医療センター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the situation and QOL of side effects on patients who meet the selection criteria
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2018 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026421
