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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007929
Receipt No. 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

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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
Institute National Hospital Organization Network Study
Institute
Department

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
URL(English) https://upload.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


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