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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023112
Receipt No. 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

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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
Email 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
Email ymiyamo@hmedc.or.jp

Sponsor
Institute Hamamatsu Medical Center, Division of Pharmacy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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