UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053287 |
|---|---|
| Receipt number | R000059628 |
| Scientific Title | Contrast enhanced ultrasound predict for surgical margin positive in breast cancer patients who had received partial mastectomy. |
| Date of disclosure of the study information | 2024/01/11 |
| Last modified on | 2024/01/07 10:55:53 |
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Basic information
Public title
Contrast enhanced ultrasound predict for surgical margin positive in breast cancer patients who had received partial mastectomy.
Acronym
Contrast enhanced ultrasound predict for surgical margin positive in breast cancer patients who had received partial mastectomy.
Scientific Title
Contrast enhanced ultrasound predict for surgical margin positive in breast cancer patients who had received partial mastectomy.
Scientific Title:Acronym
Contrast enhanced ultrasound predict for surgical margin positive in breast cancer patients who had received partial mastectomy.
Region
| Japan |
Condition
Condition
Breast cancer patients who had received partial mastectomy using contrast-enhanced ultrasound
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate risk factors of positive margins in partial mastectomy based on contrast-enhanced ultrasound.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Odds ratio for positive margin status
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients will be eligible if they meet all of the following criteria
1) Patients with a histopathological diagnosis of breast cancer
2) Patients who have undergone partial mastectomy
3) Patients who have undergone diagnosis for cancer extension in the breast using contrast-enhanced ultrasound after surgical positioning in operation room
Key exclusion criteria
Patients will be excluded if they meet any of the following criteria
1) Patients undergoing preoperative drug therapy
2) Patients undergoing preoperative irradiation
3) Patients who have requested not to participate in this study by written regretted opt-out
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1, W16, Chuo-ki, Sapporo City
TEL
+81-11-611-2111
simahiro@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shima |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
060-8543
Address
S1, W16, Chuo-ki, Sapporo City
TEL
+81-11-611-2111
Homepage URL
simahiro@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
IRB, Sapporo Medical University
Address
S1, W16, Chuo-ki, Sapporo City
Tel
+81-11-611-2111
ji-rskk@sapmed.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
| 2024 | Year | 01 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Conducted as an observational study, without intervention.
Management information
Registered date
| 2024 | Year | 01 | Month | 07 | Day |
Last modified on
| 2024 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059628
