Clinical trial · Observational
A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
Pan HER2: A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
NCT07404202CI-TRIAL-00121442Pan HER2recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a multicenter, non-interventional, descriptive study to retrospectively collect solid tumor samples from focused tumor types (NSCLC, GYN cancers, BTC and UC) and assess both assay concordance and interpretation concordance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pan-tumor(NSCLC, GYN Cancers, BTC and UC) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (4)
- label
- NSCLC
- description
- Approximately 1,000 non-small cell lung cancer samples are expected to be collected, and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest.
- label
- BTC
- description
- Approximately 500 biliary tract cancer samples are expected to be collected,and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest.
- label
- GYN
- description
- Approximately 450 gynecological cancer samples are expected to be collected, and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest.
- label
- UC
- description
- Approximately 150 urothelial carcinoma samples are expected to be collected,and 80 patients will be selected to evaluate assay concordance on confusion matrix results between 5 assays and HercepTest.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients must be at least 18 years of age 2. Male and female patients must have a histological confirmed diagnosis of NSCLC, BTC, GYN cancers, or UC between Jan 01, 2023 and Sep 30, 2025. * For GYN cancers, only cervical cancer, endometrial cancer and ovarian cancer should be included. For each gynecological cancer listed above, at least 5 cases need to be enrolled at each expression level (i.e., IHC 0/1+/2+/3+). 3. Patients must have sufficient archived tumor tissue available, with at least 15 slides suitable for HER2 status determination. Both resection or biopsy samples are acceptable. The age limit of archived tissue blocks is 5 years. Exclusion Criteria: 1. Have a history of other cancers besides NSCLC, BTC, GYN cancers and UC. 2. Specimens of patients that may affect interpretation evaluated by the researcher (e.g., frozen specimens, decalcified specimens, specimens with limited tumor content, etc.)
References
Publications (0)
Data not yet available
No reference posted for this study.