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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013264
Receipt No. R000015472
Scientific Title Study for serum estrogen concentration during aromatase inhibitor treatment
Date of disclosure of the study information 2014/02/25
Last modified on 2016/08/28

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Basic information
Public title Study for serum estrogen concentration during aromatase inhibitor treatment
Acronym Serum E2 study
Scientific Title Study for serum estrogen concentration during aromatase inhibitor treatment
Scientific Title:Acronym Serum E2 study
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study was designed to investigate intra-patient or inter-patients variability of serum E2 level during aromatase inhibitor treatments.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum E2 level on aromatase inhibitor
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 Breast cancer patients treated with AI as adjuvant therapy
Key exclusion criteria Concurrent endocrine treatment other than AI
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ishiguro
Organization Graduate School of Medicine Kyoto University
Division name Department of Target Therapy Oncology
Zip code
Address 54 Syogoinkawahara-cho, Sakyo-ku, Kyoto-city
TEL 075-751-4950
Email hkkishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Moe Tsuda
Organization Graduate School of Medicine Kyoto University
Division name Department of Breast Surgery
Zip code
Address 54 Syogoinkawahara-cho, Sakyo-ku, Kyoto-city
TEL 075-751-3660
Homepage URL
Email moe1985@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization Japan's Ministry of Education, Culture, Sports, Science and Technology
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 YES
Study ID_1 G-629
Org. issuing International ID_1 Kyoto University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 02 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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measure serum E2 level after initiation of AI for at least 4 weeks. Interval between the measure meant is at least 2 months.

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2016 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015472

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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