UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029266 |
|---|---|
| Receipt number | R000033453 |
| Scientific Title | Development of new fluorescence diagnosis in breast cancer |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2025/05/17 09:58:48 |
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Basic information
Public title
Development of new fluorescence diagnosis in breast cancer
Acronym
New diagnostic for breast cancer
Scientific Title
Development of new fluorescence diagnosis in breast cancer
Scientific Title:Acronym
Development of new fluorescence diagnosis in breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate a real time diagnostic performance
of fine needle aspiration cytology of breast cancer using 5-aminolevulinic acid.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Sensitivity and specificity of primary tumor and lymph node metastasis using fluorescence diagnosticssa
Key secondary outcomes
The comparison to the difference in fluorescence between normal and cancer cells,
The comparison to the difference in fluorescence between normal and metastatic lymph nodes,
Analysis by breast cancer subtype
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
Patients who suspected of breast cancer
Patients who diagnosed with operable breast cancer
Patients who provided signed informed consent
Key exclusion criteria
Patients who is determined inappropriate to participate in the study by the attending physician
Patients with inoperable advanced recurrent breast cancer
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Morita |
Organization
Kyoto Prefectural University of Medicine
Division name
Endocrine & Breast Surgery
Zip code
6020841
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
+81-75-251-5534
midori@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Morita |
Organization
Kyoto Prefectural University of Medicine
Division name
Endocrine & Breast Surgery
Zip code
6020841
Address
465 Kagii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
+81-75-251-5534
Homepage URL
midori@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kagii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
Tel
+81-75-251-5337
rinri@koto.kpu-m.ac.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
| 2017 | Year | 10 | 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
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033453
