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
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
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
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
