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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041620
Receipt No. R000047507
Scientific Title Local recurrence after neoadjuvant chemotherapy among breast cancer-A multicenter retrospective cohort study
Date of disclosure of the study information 2021/01/01
Last modified on 2020/08/31

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Basic information
Public title Local recurrence after neoadjuvant chemotherapy among breast cancer-A multicenter retrospective cohort study
Acronym Osaka Mie Breast Cancer
Scientific Title Local recurrence after neoadjuvant chemotherapy among breast cancer-A multicenter retrospective cohort study
Scientific Title:Acronym Osaka Mie Breast Cancer
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the risk factors of local recurrence after neoadjuvat chemotherapy (NAC) among breast cancer patients
Basic objectives2 Others
Basic objectives -Others To assess the risk factors of local recurrence after neoadjuvat chemotherapy (NAC) among breast cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the risk factors of local recurrence
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Stage 1-3 breast cancer patients who underwent definitive surgery after NAC
Key exclusion criteria patients with distant metastases at diagnosis
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Ishitobi
Organization Mie University Hospital
Division name Breast Surgery
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie
TEL 059-232-1111
Email m-ishitobi@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ishitobi
Organization Mie University Hospital
Division name Breast Surgery
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie
TEL 059-232-1111
Homepage URL
Email m-ishitobi@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Hospital
Institute
Department

Funding Source
Organization Okasan-Kato Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Clinical Research Ethics Review Committee of Mie University Hospital
Address 2-174 Edobashi, Tsu, Mie
Tel 059-231-5045
Email kk-sien@mo.medic.mie-u.ac.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
2021 Year 01 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
2020 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 08 Month 31 Day
Last modified on
2020 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047507

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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