UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045468 |
|---|---|
| Receipt number | R000051910 |
| Scientific Title | A multicenter study of patient questionnaires regarding the omission of breast surgery |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2023/03/16 09:07:56 |
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Basic information
Public title
A multicenter study of patient questionnaires regarding the omission of breast surgery
Acronym
A multicenter study of patient questionnaires regarding the omission of breast surgery
Scientific Title
A multicenter study of patient questionnaires regarding the omission of breast surgery
Scientific Title:Acronym
A multicenter study of patient questionnaires regarding the omission of breast 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 the omission of breast surgery in patients with HER2 receptor-positive or estrogen receptor-negative stage 1 to 3 breast cancer who underwent radical surgery after clinical response to preoperative chemotherapy.
Basic objectives2
Others
Basic objectives -Others
A questionnaire survey will be conducted to determine patient intentions toward the introduction of omitted breast surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient Intentions Regarding the Impact of the Introduction of Abbreviated Breast Surgery on Local Recurrence Rates and Survival
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received neoadjuvant chemotherapy for HER2 receptor-positive or estrogen receptor-negative stage 1 to 3 breast cancer between April 1, 2012 and December 31, 2020 and achieved clinical response.
Key exclusion criteria
* Patients who did not undergo curative surgery after neoadjuvant chemotherapy
* Patients with postoperative recurrence (regardless of site)
* Patients diagnosed with hereditary breast cancer-ovarian cancer syndrome
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
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
m-ishitobi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie University Hospital
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
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie
Tel
059-231-5045
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
秋田大学医学部付属病院（秋田県）、岡山大学大学病院（岡山県）、大阪国際がんセンター（大阪府）、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）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 13 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | 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
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051910
