UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013264 |
|---|---|
| Receipt number | 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 09:06:36 |
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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
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
moe1985@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015472
| 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 |
