UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007929
Receipt number R000009334
Scientific Title Study of the time to a definitive diagnosis of breast cancer in subjects in whom a work-up was indicated by mammography screening
Date of disclosure of the study information 2012/05/11
Last modified on 2019/03/22 16:13:26

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Basic information

Public title

Study of the time to a definitive diagnosis of breast cancer in subjects in whom a work-up was indicated by mammography screening

Acronym

Quality control in breast screening

Scientific Title

Study of the time to a definitive diagnosis of breast cancer in subjects in whom a work-up was indicated by mammography screening

Scientific Title:Acronym

Quality control in breast screening

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Since breast cancer screening using mammography is widely conducted, the frequency of the detection of/treatment for non-palpable breast cancer is on the rise. However, a work-up for a definitive diagnosis requires advanced diagnostic techniques, and thus even specialized institutions may not readily make such a diagnosis. Consequently, the time to a definitive diagnosis is prolonged, and in the meantime, those who should have received such a diagnosis are initially included in false-positive statistical data, degrading the screening. This study is aimed to obtain data to review the period and method of statistical data analysis of the screening process indicators by tabulating the time to a definitive diagnosis of breast cancer detected by mammography at various institutions.

Basic objectives2

Others

Basic objectives -Others

cohort, observation study

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

This study is aimed to obtain data to review the period and method of statistical data analysis of the screening process indicators by tabulating the time to a definitive diagnosis of breast cancer detected by mammography at various institutions.
The clinical and pathological features should be also examined.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1. Woman aged 20 years or older

2. A woman who underwent mammography screening (conducted by municipalities, as an option of the occupational check-up or as part of a complete medical checkup) and received a diagnosis of Category 3, 4 or 5, which require a work-up.

3. A woman who had no symptoms at the time of the screening (breast pain associated with mastopathy is considered to be symptomless)

4. A woman who received a diagnosis of breast cancer at a work-up medical institution (study site or previous institution)

5. A woman who had histopathological findings of primary breast cancer following core needle biopsy or aspiration biopsy. However, concerning women who underwent surgery for primary breast cancer without preoperative treatment, those who received a positive (malignant) diagnosis following aspiration biopsy cytology are considered eligible.

6. A woman in whom the site confirmed to be cancer is consistent with the location where the work-up is indicated by mammography screening

7. A woman who provided consent to participate in this study and who signed the Informed consent form (only for those whose images and pathological specimens described in the following 6. (2) have to be submitted for central review)

Key exclusion criteria

1.A woman who underwent both ultrasonography and mammography screenings, of which the latter did not indicate a work-up

2. A woman who visited the study site for breast cancer screening (those who visited an examination department of the study site are considered eligible)

3. A woman who visited the study site because she was worried about breast cancer

4. A woman who is considered ineligible by her attending physician

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tokiko Endo

Organization

NHO Nagoya Medical Center

Division name

radiology

Zip code


Address

4-1-1, Sannomaru, naka-ku, nagoya-city, Aichi, Japan

TEL

052-951-1111

Email

endot@nnh.hosp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tokiko Endo

Organization

National Hospital Organization Network Study

Division name

Radiology, NHO Nagoya Medical Center

Zip code


Address

4-1-1, Sannomaru, naka-ku, nagoya-city

TEL

052-951-1111

Homepage URL


Email

endot@nnh.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Network Study

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Network Study

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


Address


Tel


Email



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

2012 Year 05 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

Completed

Date of protocol fixation

2010 Year 04 Month 01 Day

Date of IRB

2010 Year 05 Month 31 Day

Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date

2013 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

(1)Information to be collected (essential items)

1.Names of the medical institution and attending physician
2.Birth date and age
3.Time of mammography screening (1st to 10th day, 11th to 20th day and 21st to 31st day of each month are classified as early, middle and late terms of the month, respectively)
4.Time of visiting the work-up medical institution (if conducted multiple times, it should be recorded)
5.Reading the mammography screening findings
6.Time of the work-up mammography and the findings if conducted
7.Time of ultrasonography of the concerned lesion and the findings
8.Time of histopathological examination of the concerned lesion and the results (CNB, MMT or surgery)
9.Time of the definitive diagnosis of breast cancer
10.Content and initiation time of presurgical treatment
11.Content and time of surgery
12.Histopathological diagnostic findings of breast cancer (including ER/PgR/HER2)

(2)Collection of images and histopathological data (obtain the consent of subjects as far as possible)

Concerning subjects who have provided consent, the following information will be obtained and registered as digital data.

For subjects in whom it has taken six months or longer from the screening visit to a definitive diagnosis of breast cancer, the original images and pathological preparations will be collected for central review and characterization of the lesion. (the above two items will be performed in reverse order)

1.Mammography screening
2.Mammography conducted at the work-up medical institution
3.Ultrasonography images
4.MRI or CT images
5.Histopathological specimens (HE preparations)


Management information

Registered date

2012 Year 05 Month 11 Day

Last modified on

2019 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009334


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name