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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003015
Receipt No. 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

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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
Email 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
Email breast@kumamoto-u.ac.jp

Sponsor
Institute Department of Breast and Endocrine Surgery,
Kumamoto University
Institute
Department

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
Email

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
URL(English) https://upload.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


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