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Clinical Trials in China / NCT07404202
Recruiting Observational

A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients

NCT07404202 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2026-03-06
Last updated
2026-10-28

Condition(s) studied

Pan-tumor(NSCLC, GYN Cancers, BTC and UC)

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.)

Primary outcome measure(s)

  • NPA of HER2 IHC 3+ based on confusion matrix results betwee other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest — From the assessment phase start to the final slides interpreted，up to approximately 6 month
    To assess the NPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\\MXB\\Zhongshan\\An Biping\\Amoy) and HercepTest
  • PPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest — From the assessment phase start to the final slides interpreted，up to approximately 6 month
    To assess the PPA of HER2 IHC 3+ based on confusion matrix results between other assays (Roche 4B5\\MXB\\Zhongshan\\An Biping\\Amoy) and HercepTest

Trial sites (14)

FacilityCityRegionStatus
Research Site Beijing China Recruiting
Research Site Changsha China Withdrawn
Research Site Chengdu China Active Not Recruiting
Research Site Guangzhou China Active Not Recruiting
Research Site Guangzhou China Withdrawn
Research Site Haerbin China Active Not Recruiting
Research Site Jinan China Active Not Recruiting
Research Site Nantong China Active Not Recruiting
Research Site Shanghai China Withdrawn
Research Site Shanghai China Recruiting
Research Site Shenyang China Active Not Recruiting
Research Site Suzhou China Withdrawn
Research Site Ürümqi China Active Not Recruiting
Research Site Zhejiang China Active Not Recruiting

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Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07404202 on ClinicalTrials.gov ↗ ← All trials in China