UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029710 |
|---|---|
| Receipt number | R000033935 |
| Scientific Title | Study on clip custody to axillary lymph node at the time of the breast cancer preoperation chemotherapy enforcement |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2017/10/25 16:15:30 |
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Basic information
Public title
Study on clip custody to axillary lymph node at the time of the breast cancer preoperation chemotherapy enforcement
Acronym
Study on clip custody to axillary lymph node at the time of the breast cancer preoperation chemotherapy enforcement
Scientific Title
Study on clip custody to axillary lymph node at the time of the breast cancer preoperation chemotherapy enforcement
Scientific Title:Acronym
Study on clip custody to axillary lymph node at the time of the breast cancer preoperation chemotherapy enforcement
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
I examine the validity of the extraction method of the clip custody lymph node using the marking clip custody to axillary lymph node and the pigment as means of the axillary lymph node evaluation precision improvement after the chemotherapy in preoperation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Identification rate of the clip custody lymph node
Key secondary outcomes
False-negative rate when evaluated the clip custody lymph node
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Detaining a clip for metastasis to axillary lymph node of the breast cancer
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Primary breast cancer patient diagnosed cT1-3N1M0 histologically.
Patient who plans standard chemotherapy before an operation
Key exclusion criteria
Patient who has more than 3 metastastic axillary lymph node
Breast cancer case of the pregnancy period or the period of lactation
Bilateral breast cancer patient of synchronism or the heterochrony
Patient with a history of other cancer witihn 5 years
Patient judged to be inadequate by medical attendant or study person in charge
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Takemae |
Organization
Tochigi Cancer Center
Division name
Department of breast sugery
Zip code
Address
4-9-13, Yonan, Utsunomiya city, Tochigi, Japan
TEL
028-658-5151
masaruta@tochigi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Takemae |
Organization
Tochigi Cancer Center
Division name
Department of breast sugery
Zip code
Address
4-9-13, Yonan, Utsunomiya city, Tochigi, Japan
TEL
028-658-5151
Homepage URL
masaruta@tochigi-cc.jp
Sponsor or person
Institute
Tochigi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Tochigi Cancer Center
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 25 | 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
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2017 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033935
