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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000007929
Enrollment
300
Registered
2012-05-11
Start date
2010-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

None listed

Sponsors

National Hospital Organization Network Study
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactTokiko Endo

National Hospital Organization Network Study Radiology, NHO Nagoya Medical Center

endot@nnh.hosp.go.jp052-951-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026