UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000014743