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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036899
Receipt No. 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 2019/05/30

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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 AKIKO
Middle name
Last name OGIYA
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
Email akiko.ogiya@jfcr.or.jp

Public contact
Name of contact person
1st name AKIKO
Middle name
Last name OGIYA
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
Email akiko.ogiya@jfcr.or.jp

Sponsor
Institute Department of Breast Surgical Oncology, Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 30 Day
Date of IRB
2019 Year 05 Month 30 Day
Anticipated trial start date
2019 Year 06 Month 24 Day
Last follow-up date
2032 Year 06 Month 23 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
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042053

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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