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A Clinical Concordance Study of Two Antibody Clones (MXR060 and SP218) for Immunohistochemical Detection of PTEN Loss in Breast Cancer

A Clinical Concordance Study of Two Antibody Clones (MXR060 and SP218) for Immunohistochemical Detection of PTEN Loss in Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121457
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Breast cancer

Interventions

Observation Group:None

Sponsors

Henan Provincial People's Hospita,medical
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Specimens consisted of surgically resected breast cancer tissues, pathologically diagnosed as HR+/HER2- breast cancer by pathologists, with complete clinical and pathological data. 2.Formalin-fixed, paraffin-embedded (FFPE) blocks were in good condition, with adequate remaining tissue to allow serial sectioning (>=3 sections, 4 µm each).

Exclusion criteria

Exclusion criteria: 1.Specimens were excluded if sections exhibited severe antigen or nucleic acid degradation resulting from long-term storage, or if clinical or pathological information was incomplete. 2.Specimens were excluded in cases of staining failure or insufficient evaluable data for interpretation.

Design outcomes

Primary

MeasureTime frame
Overall Agreement (Cohen's Kappa);Positive Percent Agreement (PPA);Negative Percent Agreement (NPA);Overall Percent Agreement (OPA);Inter-rater Agreement (Fleiss' Kappa);Sensitivity;Specificity;Accuracy;Consistency of Immunohistochemistry Staining Intensity Scores between Two PTEN Antibodies;

Countries

China

Contacts

Public ContactShi Yujie

Henan Provincial People's Hospita,medical

shiyujie523@126.com+86 371 65580256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026