UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060376 |
|---|---|
| Receipt number | R000068866 |
| Scientific Title | A Prospective Cohort Study of Breast Partial Resection for Non-Invasive Ductal Carcinoma Under Polygon-Based High-Precision Margin Detection Without Radiation Therapy |
| Date of disclosure of the study information | 2026/01/26 |
| Last modified on | 2025/12/26 12:10:11 |
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Basic information
Public title
A Prospective Cohort Study of Breast Partial Resection for Non-Invasive Ductal Carcinoma Under Polygon-Based High-Precision Margin Detection Without Radiation Therapy
Acronym
A Prospective Cohort Study of Breast Partial Resection for Non-Invasive Ductal Carcinoma Under Polygon-Based High-Precision Margin Detection Without Radiation Therapy
Scientific Title
A Prospective Cohort Study of Breast Partial Resection for Non-Invasive Ductal Carcinoma Under Polygon-Based High-Precision Margin Detection Without Radiation Therapy
Scientific Title:Acronym
A Prospective Cohort Study of Breast Partial Resection for Non-Invasive Ductal Carcinoma Under Polygon-Based High-Precision Margin Detection Without Radiation Therapy
Region
| Japan |
Condition
Condition
Ductal carcinoma in situ
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients undergoing partial mastectomy for ductal carcinoma in situ (DCIS), if the Polygon Margin Detection System,a high-precision margin detection system enabling microscopic examination of all shaved margins, yields negative results, a prospective cohort study will investigate whether the incidence of ipsilateral breast recurrence is non inferior to that observed in historical data on breast conserving surgery or in the cumulative incidence of contralateral breast cancer, thereby potentially eliminating the need for whole breast irradiation. or the cumulative incidence of contralateral breast cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-Year Cumulative Ipsilateral Breast Incidence Rate
Key secondary outcomes
3-Year Cumulative Contralateral Breast Incidence Rate
Overall Survival Rate
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients must meet all of the following criteria
Key exclusion criteria
Patients meeting any of the following criteria shall not be included in this study.
(1) Patients with active concurrent or multiple cancers (synchronous or multiple cancers, and metachronous or multiple cancers with a disease free interval of 5 years or less. However, a history of the following pathologic stages of cancer that was completely resected shall not be included as active concurrent or multiple cancer, even if the disease free interval is less than 5 years).
Gastric cancer "adenocarcinoma (general type)": Stage 0 I, Colon cancer (adenocarcinoma): Stage 0 I, Rectal cancer (adenocarcinoma): Stage 0 I, Esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma): Stage 0, Cervical cancer (squamous cell carcinoma): Stage 0, Thyroid cancer (papillary carcinoma, follicular carcinoma): Stage I, II, III, Renal cell carcinoma (clear cell carcinoma, clear cell carcinoma): Stage I
Staging classification generally follows the UICC TNM 7th edition or equivalent cancer classification guidelines.
(2) Patients confirmed to be BRCA positive.
(3) Patients with metastasis to regional lymph nodes.
(4) Patients deemed inappropriate for participation in this study by the principal investigator or co-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Breast Surgery, Breast Center
Zip code
4600001
Address
4-1-1 Sannomaru, Naka Ward, Nagoya City, Aichi Prefecture
TEL
052-951-1111
masataka.sawaki@outlook.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Breast Surgery, Breast Center
Zip code
4600001
Address
4-1-1 Sannomaru, Naka Ward, Nagoya City, Aichi Prefecture
TEL
052-951-1111
Homepage URL
masataka.sawaki@outlook.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Nagoya Medical Center
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Central Ethics Review Committee for Clinical Research
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.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
| 2026 | Year | 01 | Month | 26 | 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
| 2025 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study commenced upon approval by the National Hospital Organization Central Ethics Review Committee for Clinical Research and permission from the head of each participating institution. The observation period ends when all research subjects complete their final observation date, when the study is discontinued, or when a research subject ceases to visit the institution (i.e., when the principal investigator or co-investigator loses contact with the patient).
The research period for each subject spans from the date of informed consent acquisition to the final observation date or the discontinuation decision date. The discontinuation decision date is the date the principal investigator or co-investigator determines to discontinue the study for that subject.
Planned enrollment period: From the date of approval by the head of the implementing medical institution to the end of November 2028 (planned)
Planned observation period: 3 years and 0 months from the enrollment of the last subject
Planned total study period: 7 years and 0 months (Planned period: From the date of approval by the head of the implementing medical institution to the end of November 2032 (planned))
Management information
Registered date
| 2026 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068866
