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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013059
Receipt No. R000015238
Scientific Title Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node metastasis
Date of disclosure of the study information 2014/03/01
Last modified on 2019/07/09

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Basic information
Public title Omission of axillary lymph node dissection in
patients with clinically negative but pathologically positive sentinel-node
metastasis
Acronym JFCR B-01
Scientific Title Omission of axillary lymph node dissection in
patients with clinically negative but pathologically positive sentinel-node
metastasis
Scientific Title:Acronym JFCR B-01
Region
Japan

Condition
Condition Clinically node negative breast cancer patient
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify omission of axillary lymph node dissection could be done safely with micrometastases or one node macrometastasis only in the sentinel node .
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Distant disease-free survival
Key secondary outcomes Axillary lymph node recurrence rate
Overall survival

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 Male and Female
Key inclusion criteria 1)Breast cancer is diagnosed histologically
2)Tis,T1-T3,N0,M0
3)Age: 20 years old or older
4)Perfromance status: 0 or 1
5)Function of the main organs are good condition
6)By an explanation document, the agreements from a patient to a trial entry are provided
Key exclusion criteria 1)Ipsilateral breast tumor recurrence
2)Not prior neoadjuvant chemotherapy
3)Not pregnant or nursing
4)The patient who does not receive the the medicine
5)Examination participation of the patient is taken as inappropriate by the medical attendant
Target sample size 650

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Ogiya
Organization Cancer Institute Hospital of Japanese Foudation for Cancer Reaserch
Division name Breast Surgery
Zip code
Address 3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL 03-3520-0111
Email akiko.ogiya@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Ogiya
Organization Cancer Institute Hospital of Japanese Foudation for Cancer Reaserch
Division name Breast Surgery
Zip code
Address 3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL 03-3520-0111
Homepage URL
Email akiko.ogiya@jfcr.or.jp

Sponsor
Institute Division of Breast Surgery, Cancer Institute Hospital of Japanese Foudation for Cancer Reaserch
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2014 Year 03 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 No longer recruiting
Date of protocol fixation
2014 Year 01 Month 09 Day
Date of IRB
2014 Year 01 Month 14 Day
Anticipated trial start date
2014 Year 03 Month 19 Day
Last follow-up date
2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Palpation will be done for every six months until two years after operation and then for once a year until ten years after operation. Breast and axillary lymph node ultrasound and mammography will be done onece a year until ten years.

Management information
Registered date
2014 Year 02 Month 03 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015238

Research Plan
Registered date File name
2018/08/10 センチネル臨床試験 第6版.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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