UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047769 |
|---|---|
| Receipt number | 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 | 2025/01/08 09:53:43 |
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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
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
m-ishitobi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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
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
https://doi.org/10.1245/s10434-024-15282-
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1245/s10434-024-15282-
Number of participants that the trial has enrolled
102
Results
Of the 100 respondents, only 11 patients (11%)
preferred rBCS. Patients who had undergone rBCS and radiotherapy for IBTR were significantly more likely to prefer to undergo rBCS than other groups (p = 0.030).
The most frequent reason for choosing rBCS was the patient's desire to minimize breast deformity and surgical wounds.
Results date posted
| 2025 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria were as follows:
(1) patients who underwent BCS and axillary surgery (sentinel lymph
node biopsy only was allowed if these nodes had no metastases)
(2) patients in whom IBTR was confirmed histologically
(3) patients who underwent salvage surgery for IBTR
(4) patients with no evidence of distant recurrence at the
time of participation
(5) patients aged >18 years at participation.
Patients who had a known BRCA1 or BRCA2 pathogenic variant, or bilateral breast cancer patients were
excluded. None of the participating centers in the study recommended repeat RT throughout the entire period from the
time the questionnaire respondent was treated with IBTR to the present. This study was approved by the Institutional
Review Board at each participating institution and was conducted in accordance with the ethical principles of the Declaration of Helsinki.
Participant flow
Consecutive patients who were judged eligible to participate in this study were directly approached by one of the investigators in an outpatient setting between April 2022 and May 2023.
If the patient showed an interest in the study, detailed information was provided; patients were then approached for enrollment. Participants completed the questionnaire and posted it to the Osaka International Cancer Center or filled out a Google Form. They provided their consent via completion of the questionnaire.
Adverse events
No special note
Outcome measures
We collected clinicopathologic data (both primary tumor and IBTR) on the included patients from the participating institutions.
The following data were collected age, clinical stage, preoperative and postoperative chemotherapy, date of surgery, breast reconstruction, grade, subtype, and presence of RT to the breast or chest wall.
The Fisher test was used to evaluate correlations between patients' preferences and clinicopathologic factors and between patients' preference and the reasons for their preferences.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 16 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 16 | Day |
Other
Other related information
questionnaire survey
Management information
Registered date
| 2022 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054413
