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 |
Study of the time to a definitive diagnosis of breast cancer in subjects in whom a work-up was indicated by mammography screening
Quality control in breast screening
Study of the time to a definitive diagnosis of breast cancer in subjects in whom a work-up was indicated by mammography screening
Quality control in breast screening
Japan |
breast cancer
Breast surgery | Radiology |
Malignancy
NO
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.
Others
cohort, observation study
Not applicable
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.
Observational
20 | years-old | <= |
Not applicable |
Female
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)
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
300
1st name | |
Middle name | |
Last name | Tokiko Endo |
NHO Nagoya Medical Center
radiology
4-1-1, Sannomaru, naka-ku, nagoya-city, Aichi, Japan
052-951-1111
endot@nnh.hosp.go.jp
1st name | |
Middle name | |
Last name | Tokiko Endo |
National Hospital Organization Network Study
Radiology, NHO Nagoya Medical Center
4-1-1, Sannomaru, naka-ku, nagoya-city
052-951-1111
endot@nnh.hosp.go.jp
National Hospital Organization Network Study
National Hospital Organization Network Study
Other
NO
2012 | Year | 05 | Month | 11 | Day |
Unpublished
Completed
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 05 | Month | 31 | Day |
2010 | Year | 06 | Month | 01 | Day |
2013 | Year | 12 | Month | 31 | Day |
(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)
2012 | Year | 05 | Month | 11 | Day |
2019 | Year | 03 | Month | 22 | Day |
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 |