UMIN-CTR Clinical Trial

Public title

Investigation of correlation between the findings of contrast-enhanced ultrasound and clinicopathological factors in breast cancer.

Acronym

Investigation of correlation between the findings of contrast-enhanced ultrasound and clinicopathological factors in breast cancer.

Scientific Title

Investigation of correlation between the findings of contrast-enhanced ultrasound and clinicopathological factors in breast cancer.

Scientific Title:Acronym

Investigation of correlation between the findings of contrast-enhanced ultrasound and clinicopathological factors in breast cancer.

Region

Japan

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Masatoshi Kadoya

Organization

Ebetsu City Hospital

Division name

Surgery

Zip code

Address

6, Wakakusa-cho, Ebetsu-shi, Hokkaido, Japan

TEL

011-382-5151

Email

mkado.6809@kib.biglobe.ne.jp

Name of contact person

1st name
Middle name
Last name	Masatoshi Kadoya

Organization

Ebetsu City Hospital

Division name

Surgery

Zip code

Address

6, Wakakusa-cho, Ebetsu-shi, Hokkaido, Japan

TEL

011-382-5151

Homepage URL

Email

mkado.6809@kib.biglobe.ne.jp

Institute

Ebetsu City Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

05

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

09

Month

20

Day

Date of IRB

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

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.

Registered date

2016

Year

05

Month

16

Day

Last modified on

2016

Year

05

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025712