UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013059 |
|---|---|
| Receipt number | 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 | 2023/06/02 14:04:20 |
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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 | Uta |
| Middle name | |
| Last name | Nakadaira |
Organization
Cancer Institute Hospital of Japanese Foudation for Cancer Reaserch
Division name
Breast Surgery
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
uta.nakadaira@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Uta |
| Middle name | |
| Last name | Nakadaira |
Organization
Cancer Institute Hospital of Japanese Foudation for Cancer Reaserch
Division name
Breast Surgery
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
uta.nakadaira@jfcr.or.jp
Sponsor or person
Institute
Division of Breast Surgery, Cancer Institute Hospital of Japanese Foudation for Cancer Reaserch
Institute
Department
Personal name
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
Institutional Review Board, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address
3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel
03-3520-0111
med.shinsa@jfcr.or.jp
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
452
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
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.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 |
