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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012623
Receipt No. R000014743
Scientific Title A multicenter prospective cohort trial using of One Step Nuclei Acid Amplification Method in sentinel lymph node biopsy for early breast cancer patients
Date of disclosure of the study information 2014/01/06
Last modified on 2019/12/11

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Basic information
Public title A multicenter prospective cohort trial using of One Step Nuclei Acid Amplification Method in sentinel lymph node biopsy for early breast cancer patients
Acronym A multicenter prospective cohort trial using of One Step Nuclei Acid Amplification Method in sentinel lymph node biopsy for early breast cancer patients
Scientific Title A multicenter prospective cohort trial using of One Step Nuclei Acid Amplification Method in sentinel lymph node biopsy for early breast cancer patients
Scientific Title:Acronym A multicenter prospective cohort trial using of One Step Nuclei Acid Amplification Method in sentinel lymph node biopsy for early breast cancer patients
Region
Japan

Condition
Condition cT1-2N0M0 breast cancer patients
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to investigate whether or not to 1) omit axillary lymph node dissection (ALND) for breast cancer patient with negative-sentinel lymph node (SLN) in whole SLN analysis using the one-step nucleic acid amplification (OSNA) assay and 2) omit ALND for breast cancer patient with micrometastasis (1+) or macrometastasis (2+, +i) in SLN breast cancer patient in whole SLN analysis using OSNA assay and 3) the relationship between the cytokeratin 19 (CK19) mRNA in SLN and prognosis (ex. overall survival, disease free survival), local recurrence rate.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Disease free survival
Key secondary outcomes Overall survival, local recurrence rate, postoperative complication, non-SLN metastasis rate in patient with ALND

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) invasive breast cancer diagnosed by core needle biopsy or fine needle aspiration cytology
2) clinical T1-2N0M0
3) patient who had breast conserving surgery and mastectomy with postoperative irradiation and adjuvant therapy
4) We obtained informed consent from all patients who participated in this study.
Key exclusion criteria 1) patients who had neoaduvant therapy
2) We did not obtain informed consent from all patients who participated in this study.
Target sample size 4500

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Yotsumoto
Organization Sagara Hospital, Social Medical Corporation Hakuaikai
Division name Department of Breast Oncology
Zip code 892-0833
Address 3-31, Matsubaracho, Kagoshima, 892-0833, Japan
TEL 099-224-1800
Email yotumoto@sagara.or.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Yotsumoto
Organization Sagara Hospital, Social Medical Corporation Hakuaikai
Division name Department of Breast Oncology
Zip code 892-0833
Address 3-31, Matsubaracho, Kagoshima, 892-0833, Japan
TEL 099-224-1800
Homepage URL
Email yotumoto@sagara.or.jp

Sponsor
Institute Sagara Hospital, Social Medical Corporation Hakuaikai
Institute
Department

Funding Source
Organization Sagara Hospital, Social Medical Corporation Hakuaikai
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 Sagara Hospital, Social Medical Corporation Hakuaikai
Address 3-31, Matsubaracho, Kagoshima, 892-0833, Japan
Tel 099-224-1800
Email yotumoto@sagara.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 01 Month 06 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 Terminated
Date of protocol fixation
2013 Year 12 Month 17 Day
Date of IRB
2013 Year 05 Month 21 Day
Anticipated trial start date
2014 Year 01 Month 06 Day
Last follow-up date
2024 Year 01 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study was to investigate whether or not to 1) omit axillary lymph node dissection (ALND) for breast cancer patient with negative-sentinel lymph node (SLN) in whole SLN analysis using the one-step nucleic acid amplification (OSNA) assay and 2) omit ALND for breast cancer patient with micrometastasis (1+) or macrometastasis (2+, +i) in SLN breast cancer patient in whole SLN analysis using OSNA assay and 3) the relationship between the cytokeratin 19 (CK19) mRNA in SLN and prognosis (ex. overall survival, disease free survival), local recurrence rate.

Management information
Registered date
2013 Year 12 Month 19 Day
Last modified on
2019 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014743

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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