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

NCT07404202

RecruitingN/A

Sponsor: AstraZeneca

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

Countries: China

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 overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.)

Locations (14)

Beijing, China
Changsha, China
Chengdu, China
Guangzhou, China
Guangzhou, China
Haerbin, China
Jinan, China
Nantong, China
Shanghai, China
Shanghai, China
Shenyang, China
Suzhou, China
Ürümqi, China
Zhejiang, China