UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047529 |
|---|---|
| Receipt number | R000053885 |
| Scientific Title | Preliminary study for evaluating novel biomarker in the pathogenesis of breast cancer |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2025/04/22 09:16:05 |
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Basic information
Public title
Preliminary study for evaluating novel biomarker in the pathogenesis of breast cancer
Acronym
Preliminary study for evaluating novel biomarker in the pathogenesis of breast cancer
Scientific Title
Preliminary study for evaluating novel biomarker in the pathogenesis of breast cancer
Scientific Title:Acronym
Preliminary study for evaluating novel biomarker in the pathogenesis of breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To reveal the relationship among FES-PET, FDG-PET, and ESR1 genetic mutation observed in the patients with estrogen receptor-positive breast cancer
Basic objectives2
Others
Basic objectives -Others
Evaluating pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between the ratio of ESR1 genetic mutation and FES/FDG PET inconsistency
Key secondary outcomes
1. Relation between FES-PET findings and the pathological result of estrogen receptor
2. Relation between clinical outcome and ESR1 genetic mutation and FES/FDG PET inconsistency
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene | Device,equipment |
Interventions/Control_1
FES-PET and blood sampling for cell-free DNA analysis
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
Male and Female
Key inclusion criteria
i) Twenty years old or older when informed consent is obtained
ii) Have been diagnosed with estrogen receptor-positive breast cancer and planned new treatment or changing treatment regimen.
iii) FDG PET has been or will be performed within 60 days before or after the FES PET to be performed in this study, and no new treatment will be initiated between these two scans
iv) Have obtained consent for disclosure of FES PET results
v) Oral and written consent has been obtained
Key exclusion criteria
i) In pregnant or with the possibility of pregnancy
ii) Selective estrogen-receptor degrader or selective estrogen-receptor modulator are administered within 30 days of FES PET
iii) Referring doctor decided inappropriate to join this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamane |
Organization
Kobe City Medical Center General Hospital
Division name
Molecular Imaging Research
Zip code
650-0047
Address
Minatojima-Minamimachi 2-1-1, Chuo-ku, Kobe
TEL
078-304-4321
tomohiko_yamane@kcho.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamane |
Organization
Kobe City Medical Center General Hospital
Division name
Molecular Imaging Research
Zip code
650-0047
Address
Minatojima-Minamimachi 2-1-1, Chuo-ku, Kobe
TEL
078-304-4321
Homepage URL
tomohiko_yamane@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital Research Ethics Committee
Address
Minatojima-Minamimachi 2-1-1, Chuo-ku, Kobe
Tel
078-302-5176
rinken@kcho.jp
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
| 2022 | Year | 06 | Month | 01 | 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
| 2022 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053885
