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

Recruitingn/aAges any - anyAllAstraZeneca
NCT07404202 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.)
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What it tests

  • Not listed
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Where

14 sites
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Haerbin, China
Research Site
Jinan, China
Research Site
Nantong, China

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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