UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057179 |
|---|---|
| Receipt number | R000065350 |
| Scientific Title | The tumor bed size change after surgery of breast cancer patients undergoing breast conserving therapy. |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/02/28 18:23:01 |
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Basic information
Public title
The tumor bed size change after surgery of breast cancer patients undergoing breast conserving therapy.
Acronym
The tumor bed size change after surgery of breast cancer patients undergoing breast conserving therapy.
Scientific Title
The tumor bed size change after surgery of breast cancer patients undergoing breast conserving therapy.
Scientific Title:Acronym
The tumor bed size change after surgery of breast cancer patients undergoing breast conserving therapy.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the volumetric change in the postoperative tumor bed right after breast conserving therapy, before, and during radiotherapy, in patients with breast cancer in the Japanese surgical way; suturing of the breast cavity, where approximately the outer one-third of the mammary gland on the skin side would be apposed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Size difference of the tumor bed on CT of the breast on the next day of breast conserving therapy, before the start of radiotherapy, and before the tumor bed boost.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In addition to the usual planning CT scan before the start of radiation therapy, CT scans are taken immediately after surgery and before boost irradiation.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All cases scheduled for BCT treatment at our hospital
Key exclusion criteria
N/A
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Urayasu hospital
Division name
division of Radiation oncology departement of radiology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasushi Chibaken
TEL
047-353-3111
anne@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Urayasu Hospital
Division name
Division of radiation oncology department of radiology
Zip code
279-0021
Address
2-1-1 Tomioka Urayasushi Chibaken
TEL
047-353-3111
Homepage URL
anne@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
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
Juntendo University IRB
Address
2-1-1 Hongo Bunkyoku Tokyoto
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2025 | Year | 02 | Month | 28 | 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
46
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065350
