UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003015 |
|---|---|
| Receipt number | R000003650 |
| Scientific Title | Feasibility study on sentinel lymph node biopsy after neoadjuvant chemotherapy in node positive patients with breast cancer |
| Date of disclosure of the study information | 2010/01/12 |
| Last modified on | 2015/01/12 10:30:42 |
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Basic information
Public title
Feasibility study on sentinel lymph node biopsy after neoadjuvant chemotherapy in node positive patients with breast cancer
Acronym
Sentinel lymph node biopsy after neoadjuvant chemotherapy
Scientific Title
Feasibility study on sentinel lymph node biopsy after neoadjuvant chemotherapy in node positive patients with breast cancer
Scientific Title:Acronym
Sentinel lymph node biopsy after neoadjuvant chemotherapy
Region
| Japan |
Condition
Condition
Breast cancer with pocitive axillary node treated by neoadjuvant chemotherapy
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility study on sentinel lymph node biopsy for the patients with clinically node negative breast cancer after neoadjuvant chemotherapy who were initially confirmed of node positive by cytology or histopathology
Basic objectives2
Others
Basic objectives -Others
accuracy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
accuracy
Key secondary outcomes
adverse event, predictive factor
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
sentinel lymph node biopsy
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1. The case signed informed consent of the patients for the registration
2. The case confirmed by cytological or pathological diagnosis in primary lesion
3. The case comfirmed by cytological or pathological diagnosis in axillary lymph node before treatment
4. The case who treated by neoadjuvant chemotherapy
5. The case who will be prepared by radica operation including axilary dissection under general anesthesia
6. The case with a satisfactory function of a heart/liver/kidney/bone marrow and to satisfy the next condition
Hb: more than 8g/dl
AST(GOT), ALT(GPT): Less than 2.5 times of the normal value upper limit of the institution
Key exclusion criteria
1. The case with active other malignancies
2. The case with past history of drug allergy or hypersensitivity
3. The case during pregnancy or lactation
4. The case judged inappropriate by physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwase |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5521
hiwase@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Okabe |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5521
Homepage URL
http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
breast@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Breast and Endocrine Surgery,
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Breast and Endocrine Surgery
Faculty of Life Sciences, Kumamoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Breast and Endocrine Surgery
Nagoya City University Hospital
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
熊本大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
http://www2.kuh.kumamoto-u.ac.jp/breast/index.html
Publication of results
Partially 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 12 | Day |
Last modified on
| 2015 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003650
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
