UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018386 |
|---|---|
| Receipt number | R000021289 |
| Scientific Title | Development of New Diagnostic Method of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients. |
| Date of disclosure of the study information | 2015/07/22 |
| Last modified on | 2018/10/10 12:57:29 |
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Basic information
Public title
Development of New Diagnostic Method of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients.
Acronym
Diagnosis of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients.
Scientific Title
Development of New Diagnostic Method of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients.
Scientific Title:Acronym
Diagnosis of Sentinel Lymph Nodes and Surgical Margins Using 5-Aminolevulinic Acid in Breast Cancer Patients.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Sentinel lymph node (SLN) biopsy is a common diagnostic method in breast cancer surgery. To diagnose SLNs and surgical margins immediately, frozen pathological diagnosis is mandatory. In this study, we will develop a easier and more rapid diagnostic method using 5-aminolevulinic acid (5-ALA) in breast cancer surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
To confirm the safety of 5-ALA and the performance of the measuring instrument.
To check the matching rate between 5-ALA method and rapid or permanent pathological diagnosis of SLNs.
Key secondary outcomes
To check the matching rate between 5-ALA method and rapid or permanent pathological diagnosis of surgical margins in breast conserving therapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
5-aminolevulinic acid
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. Age older than 20 years
2 .Diagnosed with operable breast cancer
3. Informed consent is signed
Key exclusion criteria
1. Porphyria
2. With history of hypersensitivity reaction for 5-aminolevulinic acid or porphyrin
3. For whom drugs that can cause photosensitivity disease is needed
4. Apparently or possibly pregnant or have desire to be come pregnant
5. Cases who physician judged improper to entry this trial
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Taguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Endocrine & Breast Surgery
Zip code
Address
465 Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto
TEL
+81-75-251-5534
ksak@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Sakaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Endocrine & Breast Surgery
Zip code
Address
465 Kajii-cho,Kawaramachi-Hirokoji,Kamigyo-ku,Kyoto
TEL
+81-75-251-5534
Homepage URL
ksak@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT KAKENHI Grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ushio inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 22 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021289
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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