UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of correlation between the findings of contrast-enhanced ultrasound and clinicopathological factors in breast cancer.
Title of the study (Brief title)	Investigation of correlation between the findings of contrast-enhanced ultrasound and clinicopathological factors in breast cancer.
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In breast cancer, there is no examination of the correlation between extended enhancement characteristics or enhancement intensity in contrast-enhanced ultrasound (CEUS) used Sonazoid and histopathological disease parameters . For this reason, these characteristics in CEUS were focused on in this study. The correlation between enhancement size compared with the original tumor size measured by plain B-mode imaging or enhancement intensity relative to surrounding normal breast tissue and estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor type 2 (HER2) expression, subtypes, nuclear grade, and Ki67 index was studied retrospectively, and whether CEUS would contribute to the presumption of high proliferating potential in breast cancer was investigated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate the correlation between CEUS characteristics, enhancement size compared with the original tumor size measured by plain B-mode imaging or enhancement intensity relative to surrounding normal breast tissue and grade of breast cancer indicating by nuclear grade and Ki67 index.
Key secondary outcomes	1. To analysis the correlation between CEUS characteristics, enhancement size compared with the original tumor size measured by plain B-mode imaging or enhancement intensity relative to surrounding normal breast tissue and age, tumor diameter, axillary lymph node metastasis, ER, PgR, HER2 expression, subtypes. 2. In surgical specimen, to investigate HE staining histopathological image in extended enhancement region and boundary region of equal or smaller enhancement.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with breast cancer who underwent CEUS in Ebetsu City Hospital. 2. Patients with histopathologically confirmed breast cancer who underwent mastectomy or breast-conserving surgery in Ebetsu City Hospital.
Key exclusion criteria	1. Patients who underwent neoadjuvant chemotherapy. 2. Patients who did not undergo surgery. 3. Ineligible patients certified by principal investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	Masatoshi Kadoya
Organization	Ebetsu City Hospital
Division name	Surgery
Address	6, Wakakusa-cho, Ebetsu-shi, Hokkaido, Japan
TEL	011-382-5151
Email	mkado.6809@kib.biglobe.ne.jp

Public contact
Name of contact person	Masatoshi Kadoya
Organization	Ebetsu City Hospital
Division name	Surgery
Address	6, Wakakusa-cho, Ebetsu-shi, Hokkaido, Japan
TEL	011-382-5151
Homepage URL
Email	mkado.6809@kib.biglobe.ne.jp

Sponsor
Institute	Ebetsu City Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	2016 Year 05 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 20 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Histopathological results from 45 patients with breast cancer who had undergone surgery after CEUS between October 2013 and November 2015 in Ebetsu City Hospital, who met all of inclusion criteria and was not applicable to all of exclusion criteria, were investigated retrospectively.

Management information
Registered date	2016 Year 05 Month 16 Day
Last modified on	2016 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025712