A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
Recruiting now
Conditions studied: Pan-tumor(NSCLC, GYN Cancers, BTC and UC)
In brief
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.
Key facts
- Study ID
- NCT07404202
- Run by
- AstraZeneca
- People needed
- 2100
- Starts
- 2026-03-06
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-16
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be at least 18 years of age
- 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+).
- 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.
You may not qualify if…
- Have a history of other cancers besides NSCLC, BTC, GYN cancers and UC.
- Specimens of patients that may affect interpretation evaluated by the researcher (e.g., frozen specimens, decalcified specimens, specimens with limited tumor content, etc.)
Where it is running
- Research Site — Zhejiang, China (enrolling)
- Research Site — Shanghai, China (enrolling)
- Research Site — Shenyang, China (enrolling)
- Research Site — Ürümqi, China (enrolling)
- Research Site — Beijing, China (enrolling)
- Research Site — Chengdu, China (enrolling)
- Research Site — Guangzhou, China (enrolling)
- Research Site — Haerbin, China (enrolling)
- Research Site — Jinan, China (enrolling)
- Research Site — Nantong, China (enrolling)
- Research Site — Changsha, China
- Research Site — Suzhou, China
- Research Site — Shanghai, China
- Research Site — Guangzhou, China
Full record on ClinicalTrials.gov
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