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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047769
Receipt No. R000054413
Scientific Title A multicenter study of patient questionnaires regarding the Selection of Surgical Technique for Breast Recurrence after Breast Conserving Surgery
Date of disclosure of the study information 2022/05/16
Last modified on 2022/05/16

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Basic information
Public title A multicenter study of patient questionnaires regarding the Selection of Surgical Technique for Breast Recurrence after Breast Conserving Surgery
Acronym A multicenter study of patient questionnaires regarding the Selection of Surgical Technique for Breast Recurrence after Breast Conserving Surgery
Scientific Title A multicenter study of patient questionnaires regarding the Selection of Surgical Technique for Breast Recurrence after Breast Conserving Surgery
Scientific Title:Acronym A multicenter study of patient questionnaires regarding the Selection of Surgical Technique for Breast Recurrence after Breast Conserving Surgery
Region
Japan

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

Objectives
Narrative objectives1 We will conduct a questionnaire survey on surgical selection for breast cancer patients who had ipsilateral breast tumor recurrence after breast-conserving surgery and underwent radical surgery for ipsilateral breast tumor recurrence.
Basic objectives2 Others
Basic objectives -Others A questionnaire survey will be conducted to determine patient's intentions regarding the choice of surgery for ipsilateral breast tumor recurrence.
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Patient Intentions Regarding the Impact of Surgical Selection on Local Recurrence Rate and Survival for Ipsilateral Breast Tumor Recurrence
Key secondary outcomes Correlation between Patient Intentions and Background Factors on the Impact of Surgical Selection on Local Recurrence Rate and Survival for Ipsilateral Breast Tumor Recurrence

Base
Study type Others,meta-analysis etc

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with breast cancer who developed ipsilateral breast tumor recurrence after breast-conserving surgery ,and underwent radical surgery for ipsilateral breast tumor recurrence between January 1, 2012 and December 31, 2023
Key exclusion criteria *Patients who had distant recurrence at the time of ipsilateral breast tumor recurrence
*Patients of bilateral breast cancer
*Patients diagnosed with hereditary breast cancer-ovarian cancer syndrome
*Other cases that the physician in charge deemed inappropriate
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Yukiko
Middle name
Last name Seto
Organization Osaka International Cancer Institute
Division name Breast and Endocrine surgery
Zip code 541-8567
Address 3-1-69,Otemae,Chuo-ku,Osaka-shi,Osaka
TEL 06-6945-1181
Email Yukiko.seto@oici.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-shi Mie
TEL 059-232-1111
Homepage URL
Email m-ishitobi@clin.medic.mie-u.ac.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

Funding Source
Organization Osaka International Cancer Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka International Cancer Institute
Address 3-1-69,Otemae,Chuo-ku,Osaka-shi,Osaka
Tel 06-6945-1181
Email rinri01@opho.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 秋田大学医学部付属病院(秋田県)、岡山大学病院(岡山県)、近畿大学病院(大阪府)、札幌医科大学附属病院(北海道)、市立貝塚病院(大阪府)、名古屋市立大学病院(愛知県)、三重大学医学部附属病院(三重県)

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 16 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 Enrolling by invitation
Date of protocol fixation
2022 Year 03 Month 05 Day
Date of IRB
2022 Year 03 Month 05 Day
Anticipated trial start date
2022 Year 04 Month 05 Day
Last follow-up date
2024 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information questionnaire survey

Management information
Registered date
2022 Year 05 Month 16 Day
Last modified on
2022 Year 05 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054413

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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