UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036899 |
|---|---|
| Receipt number | R000042053 |
| Scientific Title | Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node macro-metastasis who undergo partial mastectomy. |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2023/06/02 14:04:59 |
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Basic information
Public title
Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node macro-metastasis who undergo partial mastectomy.
Acronym
Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node macro-metastasis who undergo partial mastectomy.
Scientific Title
Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node macro-metastasis who undergo partial mastectomy.
Scientific Title:Acronym
Omission of axillary lymph node dissection in patients with clinically negative but pathologically positive sentinel-node macro-metastasis who undergo partial mastectomy.
Region
| Japan |
Condition
Condition
breast cancer, partial mastectomy, 1 or 2 sentinel lymph nodes containing macro-metastases
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prognostic safety of omission of axillary lymph node dissection in patients with 1 or 2 sentinel lymph nodes containing macro-metastases who undergo partial mastectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distant disease-free survival
Key secondary outcomes
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) primary breast cancer
2) Tis,T1,T2,N0M0
3) partial mastectomy
4) 20 year old or older
5) Performance status(ECOCG) 0 or 1
6) preserved the function of main organs
7) obtained consent of the patient to participate in the study
Key exclusion criteria
1) ipsilateral breast tumor recurrence
2) primary systemic therapy
3) extracapsular invasion of lymph node
4) pregnancy or lactation stage
5) no systemic therapy after surgery
6) inappropriate to participate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Uta |
| Middle name | |
| Last name | Nakadaira |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Breast Surgical Oncology, Breast Oncology Center
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
0335200111
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 Foundation for Cancer Research
Division name
Department of Breast Surgical Oncology, Breast Oncology Center
Zip code
1358550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
0335200111
Homepage URL
uta.nakadaira@jfcr.or.jp
Sponsor or person
Institute
Department of Breast Surgical Oncology, Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Department of Breast Surgical Oncology, Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Self funding
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, JFCR
Address
3-8-31 Ariake, Koto-ku, Tokyo
Tel
0335200111
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
がん研究会有明病院 乳腺センター 乳腺外科
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | 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
41
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
| 2019 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2032 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Annual palpation, mammography and ultrasound is performed until 10 years after surgery.
Ultrasound check-up is performed not only breast but also residual axillary lymph node.
Axillary lymph node recurrece, local relapse, distant metastasis and survival are observed.
Management information
Registered date
| 2019 | Year | 05 | Month | 30 | 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=R000042053
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