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MammaTyper Kit

MammaTyper Kit

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018021
Enrollment
Unknown
Registered
2018-08-27
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-09-03

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

Conditions

Breast Cancer

Interventions

Gold Standard:Immunohistochemical method
Index test:PCR-&#32

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) =18 years old; (2) Female; (3) Patients diagnosed with invasive breast cancer; (4) Complete medical records (including clinical diagnosis, sex, age, date of collection, etc.); (5) At least eight 10 microns FFPE sections provided by every patient; (6) The samples containing at least 20% invasive tumor tissue, and DCIS < 40%; (7) The samples with same IHC result among 3 pathologists (The forth pathologist will be asked to measure one more times when the first three pathologists give different results, and only the results which are concordant among three of the four pathologists will be reserved.

Exclusion criteria

Exclusion criteria: (1) Patients diagnosed with special type invasive breast cancer or non-invasive breast cancer; (2) Patients who dont agree to provide samples or whose sample is not incompetent; (3) Incomplete medical records; (4) Pregnant or breast-feeding women; (5) Patients who are considered not suitable in this clinical trial by researchers; (6) The samples whose IHC results are not concordant among three of the four pathologists.

Design outcomes

Primary

MeasureTime frame
ERBB2(HER2);ESR1;PGR;MKI67 (Ki-67);

Countries

China

Contacts

Public ContactXiao Chen

Shuwen Biotech Co., Ltd.

chenx@shuwendx.cn+86 18657158841

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026