UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012623
Receipt number 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 14:21:19

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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 or person

Institute

Sagara Hospital, Social Medical Corporation Hakuaikai

Institute

Department

Personal name



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

Value
https://center6.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